N2011-01: 131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
Sponsor
New Approaches to Neuroblastoma Therapy Consortium (Other)
Overall Status
Completed
CT.gov ID
NCT02035137
Collaborator
(none)
114
14
3
79.9
8.1
0.1
Study Details
Study Description
Brief Summary
This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma
Study Start Date
:
Jul 1, 2014
Actual Primary Completion Date
:
Feb 26, 2021
Actual Study Completion Date
:
Feb 26, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Single-Agent 131I-MIBG Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. |
Radiation: 131I-MIBG
Other Names:
|
| Active Comparator: 131I-MIBG with Vincristine/Irinotecan Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. |
Radiation: 131I-MIBG
Other Names:
Drug: Vincristine
Drug: Irinotecan
|
| Active Comparator: 131I-MIBG with Vorinostat Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. |
Radiation: 131I-MIBG
Other Names:
Drug: Vorinostat
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Tumor Response After One Course of Therapy [43-50 days from study day 1]
To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.
Secondary Outcome Measures
- Number of Participants With Grade 3 or Greater Non-hematologic Toxicities [All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months]
Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must be > 24 months and < 30 years of age when registered on study.
-
Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with > 3 residual lesions on end-induction MIBG scan.
-
Patients must have evidence of MIBG uptake into tumor at ≥ one site within 4 weeks prior to entry on study and subsequent to any intervening therapy.
-
Patients must have adequate heart, kidney, liver and bone marrow function. Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.
-
Patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable CD34+ cells/kg available.
Exclusion Criteria:
-
They have had previous I-131 MIBG therapy
-
They have other medical problems that could get much worse with this treatment.
-
They are pregnant or breast feeding.
-
They have a history of a venous or arterial thrombosis that was not associated to a central line.
-
They have active infections such as hepatitis or fungal infections.
-
They have active diarrhea.
-
They have had an allogeneic stem cell transplant (received stem cell from someone else)
-
They can't cooperate with the special precautions that are needed for this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Childrens Hospital Los Angeles | Los Angeles | California | United States | 90027-0700 |
| 2 | Lucile Salter Packer Children's Hospital | Palo Alto | California | United States | 94304 |
| 3 | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
| 4 | Children Hospital of Colorado | Aurora | Colorado | United States | 80045 |
| 5 | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | United States | 30322 |
| 6 | University of Chicago, Comer Children's Hospital | Chicago | Illinois | United States | 60637 |
| 7 | Children's Hospital Boston | Boston | Massachusetts | United States | 02115 |
| 8 | C.S Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
| 9 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 10 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229-3039 |
| 11 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-4318 |
| 12 | Cook Children's Healthcare System | Fort Worth | Texas | United States | 76104 |
| 13 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 14 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G1X8 |
Sponsors and Collaborators
- New Approaches to Neuroblastoma Therapy Consortium
Investigators
- Study Chair: Steven DuBois, MD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials.gov Identifier:
NCT02035137
Other Study ID Numbers:
- N2011-01
First Posted:
Jan 14, 2014
Last Update Posted:
Jun 8, 2022
Last Verified:
May 1, 2022
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat |
|---|---|---|---|
| Arm/Group Description | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat |
| Period Title: Overall Study | |||
| STARTED | 38 | 37 | 39 |
| COMPLETED | 36 | 35 | 34 |
| NOT COMPLETED | 2 | 2 | 5 |
Baseline Characteristics
| Arm/Group Title | Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat | Total |
|---|---|---|---|---|
| Arm/Group Description | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat | Total of all reporting groups |
| Overall Participants | 38 | 36 | 37 | 111 |
| Age (Count of Participants) | ||||
| <=18 years |
37
97.4%
|
34
94.4%
|
36
97.3%
|
107
96.4%
|
| Between 18 and 65 years |
1
2.6%
|
2
5.6%
|
1
2.7%
|
4
3.6%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
19
50%
|
17
47.2%
|
16
43.2%
|
52
46.8%
|
| Male |
19
50%
|
19
52.8%
|
21
56.8%
|
59
53.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
7
18.4%
|
7
19.4%
|
10
27%
|
24
21.6%
|
| Not Hispanic or Latino |
30
78.9%
|
27
75%
|
25
67.6%
|
82
73.9%
|
| Unknown or Not Reported |
1
2.6%
|
2
5.6%
|
2
5.4%
|
5
4.5%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
1
2.6%
|
0
0%
|
0
0%
|
1
0.9%
|
| Asian |
1
2.6%
|
3
8.3%
|
2
5.4%
|
6
5.4%
|
| Native Hawaiian or Other Pacific Islander |
1
2.6%
|
0
0%
|
0
0%
|
1
0.9%
|
| Black or African American |
4
10.5%
|
4
11.1%
|
4
10.8%
|
12
10.8%
|
| White |
26
68.4%
|
23
63.9%
|
23
62.2%
|
72
64.9%
|
| More than one race |
1
2.6%
|
1
2.8%
|
1
2.7%
|
3
2.7%
|
| Unknown or Not Reported |
4
10.5%
|
5
13.9%
|
7
18.9%
|
16
14.4%
|
| Region of Enrollment (participants) [Number] | ||||
| Canada |
1
2.6%
|
1
2.8%
|
1
2.7%
|
3
2.7%
|
| United States |
37
97.4%
|
35
97.2%
|
36
97.3%
|
108
97.3%
|
Outcome Measures
| Title | Objective Tumor Response After One Course of Therapy |
|---|---|
| Description | To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR. |
| Time Frame | 43-50 days from study day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of eligible randomized patients who received 131-I-MIBG therapy |
| Arm/Group Title | Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat |
|---|---|---|---|
| Arm/Group Description | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat |
| Measure Participants | 36 | 35 | 34 |
| Count of Participants [Participants] |
5
13.2%
|
5
13.9%
|
11
29.7%
|
| Title | Number of Participants With Grade 3 or Greater Non-hematologic Toxicities |
|---|---|
| Description | Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG |
| Time Frame | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who were eligible, randomized, and received 131I-MIBG treatment |
| Arm/Group Title | Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat |
|---|---|---|---|
| Arm/Group Description | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat |
| Measure Participants | 36 | 35 | 34 |
| Count of Participants [Participants] |
7
18.4%
|
17
47.2%
|
12
32.4%
|
Adverse Events
| Time Frame | All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module | |||||
| Arm/Group Title | Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat | |||
| Arm/Group Description | Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG | Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan | Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat | |||
All Cause Mortality |
||||||
| Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/38 (28.9%) | 17/36 (47.2%) | 18/37 (48.6%) | |||
Serious Adverse Events |
||||||
| Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/38 (15.8%) | 12/36 (33.3%) | 5/37 (13.5%) | |||
| Blood and lymphatic system disorders | ||||||
| 10002272-Anemia | 4/38 (10.5%) | 6/36 (16.7%) | 0/37 (0%) | |||
| 10016288-Febrile neutropenia | 2/38 (5.3%) | 3/36 (8.3%) | 0/37 (0%) | |||
| Cardiac disorders | ||||||
| 10040752-Sinus tachycardia | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Eye disorders | ||||||
| 10034960-Photophobia | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Gastrointestinal disorders | ||||||
| 10000060-Abdominal distension | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10000081-Abdominal pain | 0/38 (0%) | 3/36 (8.3%) | 0/37 (0%) | |||
| 10010774-Constipation | 0/38 (0%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10012727-Diarrhea | 0/38 (0%) | 3/36 (8.3%) | 0/37 (0%) | |||
| 10013781-Dry mouth | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10021328-Ileus | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10028813-Nausea | 0/38 (0%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10047700-Vomiting | 0/38 (0%) | 4/36 (11.1%) | 1/37 (2.7%) | |||
| General disorders | ||||||
| 10016256-Fatigue | 0/38 (0%) | 3/36 (8.3%) | 1/37 (2.7%) | |||
| 10016558-Fever | 1/38 (2.6%) | 1/36 (2.8%) | 2/37 (5.4%) | |||
| Infections and infestations | ||||||
| 10007810-Catheter related infection | 1/38 (2.6%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10059827-Rhinitis infective | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| CLOSTRIDIUM DIFFICILE | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| ENTEROBACTER CLOCACAE | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| Investigations | ||||||
| 10025256-Lymphocyte count decreased | 1/38 (2.6%) | 3/36 (8.3%) | 0/37 (0%) | |||
| 10029366-Neutrophil count decreased | 0/38 (0%) | 4/36 (11.1%) | 0/37 (0%) | |||
| 10035528-Platelet count decreased | 2/38 (5.3%) | 5/36 (13.9%) | 1/37 (2.7%) | |||
| 10047900-Weight loss | 0/38 (0%) | 3/36 (8.3%) | 0/37 (0%) | |||
| 10049182-White blood cell decreased | 1/38 (2.6%) | 5/36 (13.9%) | 1/37 (2.7%) | |||
| Metabolism and nutrition disorders | ||||||
| 10002646-Anorexia | 0/38 (0%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10012174-Dehydration | 0/38 (0%) | 3/36 (8.3%) | 0/37 (0%) | |||
| 10020943-Hypoalbuminemia | 1/38 (2.6%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10020949-Hypocalcemia | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10021018-Hypokalemia | 1/38 (2.6%) | 2/36 (5.6%) | 1/37 (2.7%) | |||
| 10021038-Hyponatremia | 0/38 (0%) | 4/36 (11.1%) | 0/37 (0%) | |||
| 10021059-Hypophosphatemia | 0/38 (0%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| 10003988-Back pain | 1/38 (2.6%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10028411-Myalgia | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10033425-Pain in extremity | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10048677-Buttock pain | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| 10049737-Treatment related secondary malignancy | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| PILONIDAL CYST | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| Nervous system disorders | ||||||
| 10019211-Headache | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10024264-Lethargy | 0/38 (0%) | 2/36 (5.6%) | 0/37 (0%) | |||
| Psychiatric disorders | ||||||
| 10022437-Insomnia | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| 10011224-Cough | 1/38 (2.6%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10021143-Hypoxia | 1/38 (2.6%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10035598-Pleural effusion | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Single-Agent 131I-MIBG | 131I-MIBG With Vincristine/Irinotecan | 131I-MIBG With Vorinostat | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 37/38 (97.4%) | 35/36 (97.2%) | 35/37 (94.6%) | |||
| Blood and lymphatic system disorders | ||||||
| 10002272-Anemia | 34/38 (89.5%) | 33/36 (91.7%) | 32/37 (86.5%) | |||
| 10016288-Febrile neutropenia | 2/38 (5.3%) | 4/36 (11.1%) | 0/37 (0%) | |||
| Cardiac disorders | ||||||
| 10040741-Sinus bradycardia | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10040752-Sinus tachycardia | 4/38 (10.5%) | 7/36 (19.4%) | 5/37 (13.5%) | |||
| MURMUR | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| Ear and labyrinth disorders | ||||||
| 10014020-Ear pain | 1/38 (2.6%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10019245-Hearing impaired | 0/38 (0%) | 2/36 (5.6%) | 1/37 (2.7%) | |||
| 10065838-Middle ear inflammation | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Endocrine disorders | ||||||
| 10021114-Hypothyroidism | 1/38 (2.6%) | 3/36 (8.3%) | 1/37 (2.7%) | |||
| UNCOMPENSATED HYPOTHYROIDISM | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Eye disorders | ||||||
| 10005886-Blurred vision | 1/38 (2.6%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10015958-Eye pain | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10016778-Floaters | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10034960-Photophobia | 2/38 (5.3%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10061322-Optic nerve disorder | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| INJECTED EYE | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Gastrointestinal disorders | ||||||
| 10000060-Abdominal distension | 1/38 (2.6%) | 1/36 (2.8%) | 2/37 (5.4%) | |||
| 10000081-Abdominal pain | 7/38 (18.4%) | 11/36 (30.6%) | 2/37 (5.4%) | |||
| 10002167-Anal pain | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10009887-Colitis | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10010774-Constipation | 7/38 (18.4%) | 11/36 (30.6%) | 7/37 (18.9%) | |||
| 10012727-Diarrhea | 4/38 (10.5%) | 24/36 (66.7%) | 8/37 (21.6%) | |||
| 10013781-Dry mouth | 2/38 (5.3%) | 2/36 (5.6%) | 3/37 (8.1%) | |||
| 10013946-Dyspepsia | 1/38 (2.6%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10021328-Ileus | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10028130-Mucositis oral | 1/38 (2.6%) | 4/36 (11.1%) | 2/37 (5.4%) | |||
| 10028813-Nausea | 14/38 (36.8%) | 23/36 (63.9%) | 13/37 (35.1%) | |||
| 10030980-Oral hemorrhage | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10031009-Oral pain | 2/38 (5.3%) | 3/36 (8.3%) | 1/37 (2.7%) | |||
| 10038064-Rectal hemorrhage | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10038072-Rectal pain | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10042112-Stomach pain | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10044055-Toothache | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10047700-Vomiting | 15/38 (39.5%) | 21/36 (58.3%) | 20/37 (54.1%) | |||
| 10066874-Gastroesophageal reflux disease | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| STOMACH CRAMPING | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| General disorders | ||||||
| 10008531-Chills | 0/38 (0%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| 10014222-Edema face | 2/38 (5.3%) | 7/36 (19.4%) | 2/37 (5.4%) | |||
| 10016059-Facial pain | 0/38 (0%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| 10016256-Fatigue | 11/38 (28.9%) | 16/36 (44.4%) | 12/37 (32.4%) | |||
| 10016558-Fever | 10/38 (26.3%) | 10/36 (27.8%) | 10/37 (27%) | |||
| 10016791-Flu like symptoms | 1/38 (2.6%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10017577-Gait disturbance | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10022998-Irritability | 1/38 (2.6%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10025482-Malaise | 2/38 (5.3%) | 2/36 (5.6%) | 2/37 (5.4%) | |||
| 10033371-Pain | 2/38 (5.3%) | 8/36 (22.2%) | 4/37 (10.8%) | |||
| 10050068-Edema limbs | 1/38 (2.6%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10051792-Infusion related reaction | 1/38 (2.6%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10054482-Neck edema | 0/38 (0%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| 10062466-Localized edema | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10062501-Non-cardiac chest pain | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| CHEST DISCOMFORT, ""TIGHTNESS"" | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| CONCERN FOR DISEASE PROGRESSION AS INDICATED BY INTERVAL INCREASE IN THE SIZE OF HER OCCIPITAL MASS | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| IRRITATION AROUND CATHETER | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| PAIN | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| PAIN RIGHT SIDE JAW | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Immune system disorders | ||||||
| 10001718-Allergic reaction | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Infections and infestations | ||||||
| 10007810-Catheter related infection | 2/38 (5.3%) | 2/36 (5.6%) | 1/37 (2.7%) | |||
| 10040047-Sepsis | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10040872-Skin infection | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10046300-Upper respiratory infection | 1/38 (2.6%) | 4/36 (11.1%) | 1/37 (2.7%) | |||
| 10046571-Urinary tract infection | 3/38 (7.9%) | 0/36 (0%) | 0/37 (0%) | |||
| 10065764-Mucosal infection | 0/38 (0%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| C DIFFICILE | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| CLOSTRIDIUM DIFICILE | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| ENTEROBACTER CLOACAE | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| INFLUENZA A | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| MULTIPLE BACTERIAL INFECTIONS (ENTEROBACTER, CITROBACTER, KLEBSIELLA, GPC, GVC) | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| PAROTIDITIS | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| RHINOVIRUS | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| 10006504-Bruising | 3/38 (7.9%) | 1/36 (2.8%) | 4/37 (10.8%) | |||
| 10017076-Fracture | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| INJURY TO LEFT WRIST | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| SCRATCH | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Investigations | ||||||
| 10000636-Activated partial thromboplastin time prolonged | 3/38 (7.9%) | 2/36 (5.6%) | 16/37 (43.2%) | |||
| 10001551-Alanine aminotransferase increased | 21/38 (55.3%) | 22/36 (61.1%) | 17/37 (45.9%) | |||
| 10001675-Alkaline phosphatase increased | 7/38 (18.4%) | 2/36 (5.6%) | 5/37 (13.5%) | |||
| 10003481-Aspartate aminotransferase increased | 23/38 (60.5%) | 21/36 (58.3%) | 21/37 (56.8%) | |||
| 10005364-Blood bilirubin increased | 3/38 (7.9%) | 3/36 (8.3%) | 3/37 (8.1%) | |||
| 10007839-CD4 lymphocytes decreased | 1/38 (2.6%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10011368-Creatinine increased | 1/38 (2.6%) | 1/36 (2.8%) | 4/37 (10.8%) | |||
| 10014383-Electrocardiogram QT corrected interval prolonged | 0/38 (0%) | 0/36 (0%) | 3/37 (8.1%) | |||
| 10022402-INR increased | 2/38 (5.3%) | 1/36 (2.8%) | 6/37 (16.2%) | |||
| 10025256-Lymphocyte count decreased | 27/38 (71.1%) | 28/36 (77.8%) | 28/37 (75.7%) | |||
| 10025258-Lymphocyte count increased | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10029366-Neutrophil count decreased | 34/38 (89.5%) | 31/36 (86.1%) | 31/37 (83.8%) | |||
| 10035528-Platelet count decreased | 35/38 (92.1%) | 34/36 (94.4%) | 34/37 (91.9%) | |||
| 10047900-Weight loss | 1/38 (2.6%) | 9/36 (25%) | 5/37 (13.5%) | |||
| 10049182-White blood cell decreased | 32/38 (84.2%) | 33/36 (91.7%) | 30/37 (81.1%) | |||
| 10056910-GGT increased | 1/38 (2.6%) | 1/36 (2.8%) | 2/37 (5.4%) | |||
| HYPERPHOSPHATEMIA | 1/38 (2.6%) | 0/36 (0%) | 1/37 (2.7%) | |||
| Metabolism and nutrition disorders | ||||||
| 10002646-Anorexia | 10/38 (26.3%) | 15/36 (41.7%) | 14/37 (37.8%) | |||
| 10012174-Dehydration | 0/38 (0%) | 7/36 (19.4%) | 2/37 (5.4%) | |||
| 10020587-Hypercalcemia | 2/38 (5.3%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| 10020639-Hyperglycemia | 7/38 (18.4%) | 5/36 (13.9%) | 10/37 (27%) | |||
| 10020647-Hyperkalemia | 2/38 (5.3%) | 2/36 (5.6%) | 2/37 (5.4%) | |||
| 10020670-Hypermagnesemia | 6/38 (15.8%) | 2/36 (5.6%) | 7/37 (18.9%) | |||
| 10020680-Hypernatremia | 1/38 (2.6%) | 0/36 (0%) | 2/37 (5.4%) | |||
| 10020870-Hypertriglyceridemia | 1/38 (2.6%) | 4/36 (11.1%) | 0/37 (0%) | |||
| 10020943-Hypoalbuminemia | 8/38 (21.1%) | 11/36 (30.6%) | 11/37 (29.7%) | |||
| 10020949-Hypocalcemia | 8/38 (21.1%) | 9/36 (25%) | 8/37 (21.6%) | |||
| 10021005-Hypoglycemia | 1/38 (2.6%) | 2/36 (5.6%) | 2/37 (5.4%) | |||
| 10021018-Hypokalemia | 8/38 (21.1%) | 10/36 (27.8%) | 10/37 (27%) | |||
| 10021028-Hypomagnesemia | 7/38 (18.4%) | 13/36 (36.1%) | 4/37 (10.8%) | |||
| 10021038-Hyponatremia | 14/38 (36.8%) | 15/36 (41.7%) | 13/37 (35.1%) | |||
| 10021059-Hypophosphatemia | 7/38 (18.4%) | 6/36 (16.7%) | 8/37 (21.6%) | |||
| 10065973-Iron overload | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| MALNUTRITION - ANOREXIA | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| VITAMIN D DEFICIENCY | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| 10003988-Back pain | 3/38 (7.9%) | 2/36 (5.6%) | 3/37 (8.1%) | |||
| 10006002-Bone pain | 5/38 (13.2%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10008496-Chest wall pain | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10028411-Myalgia | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10028836-Neck pain | 3/38 (7.9%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10033425-Pain in extremity | 3/38 (7.9%) | 6/36 (16.7%) | 2/37 (5.4%) | |||
| 10048677-Buttock pain | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10062572-Generalized muscle weakness | 0/38 (0%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10065776-Muscle weakness lower limb | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10065780-Muscle weakness left-sided | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| JAW PAIN | 0/38 (0%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| PAIN IN EXTREMITY -RIGHT FOOT | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| PAIN, LEG | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| RIB PAIN | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| 10045158-Tumor pain | 1/38 (2.6%) | 0/36 (0%) | 2/37 (5.4%) | |||
| DISEASE PROGRESSION | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| PILONIDAL CYST | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| Nervous system disorders | ||||||
| 10013573-Dizziness | 1/38 (2.6%) | 2/36 (5.6%) | 1/37 (2.7%) | |||
| 10013911-Dysgeusia | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10019211-Headache | 7/38 (18.4%) | 6/36 (16.7%) | 5/37 (13.5%) | |||
| 10024264-Lethargy | 1/38 (2.6%) | 4/36 (11.1%) | 0/37 (0%) | |||
| 10033987-Paresthesia | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10034620-Peripheral sensory neuropathy | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10041349-Somnolence | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| Psychiatric disorders | ||||||
| 10001497-Agitation | 0/38 (0%) | 1/36 (2.8%) | 2/37 (5.4%) | |||
| 10002855-Anxiety | 2/38 (5.3%) | 2/36 (5.6%) | 3/37 (8.1%) | |||
| 10012378-Depression | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10022437-Insomnia | 1/38 (2.6%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10042458-Suicidal ideation | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| ADJUSTMENT DISORDER | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| ODD/ANXIETY | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Renal and urinary disorders | ||||||
| 10019450-Hematuria | 2/38 (5.3%) | 2/36 (5.6%) | 1/37 (2.7%) | |||
| 10037032-Proteinuria | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10046539-Urinary frequency | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10046555-Urinary retention | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10048994-Bladder spasm | 1/38 (2.6%) | 2/36 (5.6%) | 0/37 (0%) | |||
| 10062225-Urinary tract pain | 2/38 (5.3%) | 0/36 (0%) | 0/37 (0%) | |||
| CATHETER RELATED PAIN | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| DYSURIA | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| KETONURIA | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| URETHRAL TRAUMA | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| Reproductive system and breast disorders | ||||||
| 10034310-Penile pain | 2/38 (5.3%) | 2/36 (5.6%) | 2/37 (5.4%) | |||
| PARAPHIMOSIS | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| 10001723-Allergic rhinitis | 4/38 (10.5%) | 1/36 (2.8%) | 2/37 (5.4%) | |||
| 10011224-Cough | 12/38 (31.6%) | 8/36 (22.2%) | 11/37 (29.7%) | |||
| 10013963-Dyspnea | 2/38 (5.3%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| 10015090-Epistaxis | 2/38 (5.3%) | 2/36 (5.6%) | 1/37 (2.7%) | |||
| 10020039-Hiccups | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| 10021143-Hypoxia | 0/38 (0%) | 0/36 (0%) | 2/37 (5.4%) | |||
| 10028735-Nasal congestion | 5/38 (13.2%) | 3/36 (8.3%) | 6/37 (16.2%) | |||
| 10035598-Pleural effusion | 1/38 (2.6%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10036790-Productive cough | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10038695-Respiratory failure | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10041232-Sneezing | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10041367-Sore throat | 4/38 (10.5%) | 7/36 (19.4%) | 2/37 (5.4%) | |||
| RESPIRATORY DEPRESSION FROM SEDATION | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| RHINORRHEA | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| 10001760-Alopecia | 0/38 (0%) | 5/36 (13.9%) | 2/37 (5.4%) | |||
| 10013786-Dry skin | 3/38 (7.9%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10037087-Pruritus | 2/38 (5.3%) | 1/36 (2.8%) | 0/37 (0%) | |||
| 10037868-Rash maculo-papular | 1/38 (2.6%) | 1/36 (2.8%) | 1/37 (2.7%) | |||
| 10040865-Skin hyperpigmentation | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| DRY CRACKED LIPS | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| ECZEMA | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| PAPULOERYTHEMATOUS LESIONS - LEFT CHEEK | 1/38 (2.6%) | 0/36 (0%) | 0/37 (0%) | |||
| RASH - CHEST | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| RASH - UPPER CHEST AND BACK | 0/38 (0%) | 1/36 (2.8%) | 0/37 (0%) | |||
| Vascular disorders | ||||||
| 10016825-Flushing | 0/38 (0%) | 0/36 (0%) | 1/37 (2.7%) | |||
| 10020772-Hypertension | 3/38 (7.9%) | 4/36 (11.1%) | 3/37 (8.1%) | |||
| 10021097-Hypotension | 1/38 (2.6%) | 2/36 (5.6%) | 4/37 (10.8%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | NANT Medical Director |
|---|---|
| Organization | New Advances in Neuroblastoma Therapy |
| Phone | 3233615687 |
| nantops@chla.usc.edu |
Responsible Party:
New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials.gov Identifier:
NCT02035137
Other Study ID Numbers:
- N2011-01
First Posted:
Jan 14, 2014
Last Update Posted:
Jun 8, 2022
Last Verified:
May 1, 2022