Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
Study Details
Study Description
Brief Summary
RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.
PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin.
Secondary
-
Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug.
-
Determine the toxicity of this drug in these patients.
-
Determine the infection rate in patients treated with this drug.
-
Determine the pharmacokinetics of this drug in these patients.
-
Determine the changes in lymphocyte populations in patients treated with this drug.
-
Determine the survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.
Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pentostatin treatment of pts with refractory graft vs host disease |
Drug: pentostatin
4 mg/sq m IV infusion over 20-30 min q 2 weeks
|
Outcome Measures
Primary Outcome Measures
- Response Rate [3 months]
Percentage of participants who had a complete or partial response defined by the Hopkins scoring system. A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.
Secondary Outcome Measures
- Grade 3 or Higher Non-hematologic Adverse Events [Duration of treatment (up to 5 years)]
Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.
- Overall Survival At 1 Year [1 year]
Percentage of patients who were alive at 1 year.
- Overall Survival At 2 Years [2 year]
Percentage of patients who were alive at 2 years.
Other Outcome Measures
- Pharmacokinetics Association Between Exposure and Response At 3 Months [3 months]
The individual PK parameters will be derived by using a noncompartmental analysis of the plasma-concentration-time data
Eligibility Criteria
Criteria
-
Histologic documentation of chronic GvHD following allogeneic HCT or donor lymphocyte infusion.
-
Patients may have progressive, quiescent, or de novo onset chronic GvHD.
-
Patients with extensive stage chronic GvHD requiring systemic immunosuppressive therapy are eligible. Patients with limited stage disease are excluded. Extensive stage is defined according to Seattle criteria (9) as either:
-
Generalized skin involvement or
-
Limited skin involvement or hepatic involvement with any one of the following:
-
Liver histology showing chronic progressive hepatitis, bridging necrosis or cirrhosis
-
Eye involvement (Schirmer's test with < 5 mm wetting)
-
Involvement of minor salivary glands or oral mucosa
-
Involvement of any other organ
- Patients must have failed treatment with, or experience progression after, prior corticosteroids for extensive stage chronic GvHD, as defined below.
4.1 Patients will be considered to have failed corticosteroids if they have any one of the following criteria:
-
Progressive disease or less than a minor response in any organ system despite 2 weeks on corticosteroid treatment at least 1 mg/kg methylprednisolone or equivalent.
-
Failure to achieve at least a minor response after at least 4 weeks of treatment with a dose of ≥ 0.5 mg/kg methylprednisolone or equivalent.
-
Achievement of less than a partial response at 8 weeks of corticosteroid treatment despite use of a dose ≥ 0.5 mg/kg methylprednisolone or equivalent.
-
Requirement of ≥ 0.5 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 12 weeks of corticosteroid treatment.
-
Requirement of > 10 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 18 weeks of corticosteroid treatment.
4.2 Patients with progression of extensive stage chronic GvHD after a prior history of treatment with at least 18 weeks of corticosteroids, now requiring the reintroduction of corticosteroids (> 10 mg/day methylprednisolone or equivalent) or an additional agent (including photopheresis, PUVA) for treatment.
-
Patients with established chronic GvHD not improving or progressing on other immunosuppressive agents are also eligible if steroid refractoriness has been established previously.
-
Age ≥ 18 years
-
Performance Status 0-3
-
Patients on mechanical ventilation are excluded.
-
No active infection. Patients with active infection requiring antibiotic therapy are not eligible until infection is controlled.
-
No HIV infection. Patients with HIV infection are excluded because of safety concerns in this patient population.
-
Non-pregnant and non-nursing. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial (although it is unlikely that successful pregnancy will occur in patients with chronic GvHD). Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).
-
Required Initial Laboratory Values:
-
Calc. Creatinine Clearance ≥ 30 mL/min/1.73 m^2
-
ANC > 1000/μL
-
Platelets > 50,000/μL without transfusion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
2 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
3 | University of Illinois Cancer Center | Chicago | Illinois | United States | 60612-7243 |
4 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
5 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
6 | Union Hospital Cancer Program at Union Hospital | Elkton | Maryland | United States | 21921 |
7 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
8 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
9 | New York Weill Cornell Cancer Center at Cornell University | New York | New York | United States | 10021 |
10 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
11 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
12 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | United States | 43210-1240 |
13 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-4283 |
14 | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | United States | 19111-2497 |
15 | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224-1791 |
16 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Sherif S. Farag, MD, PhD, Ohio State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CALGB-100101
- U10CA031946
- CDR0000341678
Study Results
Participant Flow
Recruitment Details | Between December 2003 and March 2008, 39 participants were recruited to this study. |
---|---|
Pre-assignment Detail | 1 participant cancelled prior to receiving treatment and is excluded from all analyses. |
Arm/Group Title | Pentostatin |
---|---|
Arm/Group Description | pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks |
Period Title: Overall Study | |
STARTED | 38 |
COMPLETED | 38 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Pentostatin |
---|---|
Arm/Group Description | pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks |
Overall Participants | 38 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
48
|
Sex: Female, Male (Count of Participants) | |
Female |
13
34.2%
|
Male |
25
65.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
2
5.3%
|
Not Hispanic or Latino |
29
76.3%
|
Unknown or Not Reported |
7
18.4%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
1
2.6%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
3
7.9%
|
White |
30
78.9%
|
More than one race |
1
2.6%
|
Unknown or Not Reported |
3
7.9%
|
Region of Enrollment (count of participants) [Number] | |
United States |
38
100%
|
Outcome Measures
Title | Response Rate |
---|---|
Description | Percentage of participants who had a complete or partial response defined by the Hopkins scoring system. A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
3 patients died before the 3 month evaluation and were not evaluated for the primary endpoint |
Arm/Group Title | Pentostatin |
---|---|
Arm/Group Description | pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks |
Measure Participants | 35 |
Number [percentage of participants] |
20
52.6%
|
Title | Grade 3 or Higher Non-hematologic Adverse Events |
---|---|
Description | Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment. |
Time Frame | Duration of treatment (up to 5 years) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Pentostatin |
---|---|
Arm/Group Description | pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks |
Measure Participants | 38 |
Fatigue |
3
7.9%
|
Renal failure |
4
10.5%
|
Anorexia |
2
5.3%
|
Infection |
10
26.3%
|
CNS hemmorrhage |
1
2.6%
|
Rash |
1
2.6%
|
Personality/behavioral |
1
2.6%
|
Pneumonitis |
1
2.6%
|
Title | Overall Survival At 1 Year |
---|---|
Description | Percentage of patients who were alive at 1 year. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Pentostatin |
---|---|
Arm/Group Description | pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks |
Measure Participants | 38 |
Number [percentage of participants] |
53
139.5%
|
Title | Overall Survival At 2 Years |
---|---|
Description | Percentage of patients who were alive at 2 years. |
Time Frame | 2 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Pentostatin |
---|---|
Arm/Group Description | pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks |
Measure Participants | 38 |
Number [percentage of participants] |
50
131.6%
|
Title | Pharmacokinetics Association Between Exposure and Response At 3 Months |
---|---|
Description | The individual PK parameters will be derived by using a noncompartmental analysis of the plasma-concentration-time data |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | 34 participants were evaluable for adverse events | |
Arm/Group Title | Pentostatin | |
Arm/Group Description | pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks | |
All Cause Mortality |
||
Pentostatin | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Pentostatin | ||
Affected / at Risk (%) | # Events | |
Total | 14/34 (41.2%) | |
Blood and lymphatic system disorders | ||
Hemoglobin decreased | 11/34 (32.4%) | 16 |
Cardiac disorders | ||
Atrial tachycardia | 1/34 (2.9%) | 1 |
Cardiac disorder | 1/34 (2.9%) | 1 |
Edema | 1/34 (2.9%) | 2 |
Sinus tachycardia | 1/34 (2.9%) | 1 |
Eye disorders | ||
Dry eye syndrome | 4/34 (11.8%) | 8 |
Eye disorder | 1/34 (2.9%) | 1 |
Eye pain | 1/34 (2.9%) | 1 |
Photophobia | 1/34 (2.9%) | 1 |
Gastrointestinal disorders | ||
Abdominal pain | 1/34 (2.9%) | 1 |
Constipation | 1/34 (2.9%) | 1 |
Diarrhea | 6/34 (17.6%) | 8 |
Dry mouth | 4/34 (11.8%) | 5 |
Dysphagia | 1/34 (2.9%) | 2 |
Ear, nose and throat examination abnormal | 2/34 (5.9%) | 2 |
Gastric hemorrhage | 1/34 (2.9%) | 1 |
Gastrointestinal disorder | 1/34 (2.9%) | 1 |
Nausea | 3/34 (8.8%) | 3 |
Vomiting | 2/34 (5.9%) | 2 |
General disorders | ||
Chills | 1/34 (2.9%) | 1 |
Edema limbs | 1/34 (2.9%) | 1 |
Fatigue | 3/34 (8.8%) | 4 |
Fever | 2/34 (5.9%) | 2 |
General symptom | 1/34 (2.9%) | 1 |
Injection site reaction | 1/34 (2.9%) | 1 |
Localized edema | 2/34 (5.9%) | 2 |
Pain | 3/34 (8.8%) | 3 |
Hepatobiliary disorders | ||
Hepatobiliary disease | 1/34 (2.9%) | 4 |
Immune system disorders | ||
Immune system disorder | 1/34 (2.9%) | 2 |
Infections and infestations | ||
Catheter related infection | 1/34 (2.9%) | 1 |
Infection without neutropenia | 3/34 (8.8%) | 4 |
Opportunistic infection | 1/34 (2.9%) | 1 |
Phlebitis infective | 1/34 (2.9%) | 1 |
Sinusitis | 1/34 (2.9%) | 1 |
Injury, poisoning and procedural complications | ||
Vascular access complication | 1/34 (2.9%) | 1 |
Investigations | ||
Alanine aminotransferase increased | 9/34 (26.5%) | 15 |
Alkaline phosphatase | 4/34 (11.8%) | 8 |
Alkaline phosphatase increased | 5/34 (14.7%) | 7 |
Aspartate aminotransferase increased | 11/34 (32.4%) | 17 |
Blood bilirubin increased | 7/34 (20.6%) | 11 |
Coagulopathy | 1/34 (2.9%) | 1 |
Creatinine increased | 8/34 (23.5%) | 12 |
Laboratory test abnormal | 4/34 (11.8%) | 7 |
Leukocyte count decreased | 7/34 (20.6%) | 11 |
Lymphocyte count decreased | 2/34 (5.9%) | 3 |
Neutrophil count decreased | 5/34 (14.7%) | 5 |
Platelet count decreased | 8/34 (23.5%) | 11 |
Serum cholesterol increased | 2/34 (5.9%) | 2 |
Weight loss | 2/34 (5.9%) | 5 |
Metabolism and nutrition disorders | ||
Anorexia | 4/34 (11.8%) | 5 |
Blood bicarbonate decreased | 3/34 (8.8%) | 6 |
Blood glucose increased | 7/34 (20.6%) | 8 |
Dehydration | 5/34 (14.7%) | 7 |
Iron overload | 1/34 (2.9%) | 1 |
Serum albumin decreased | 7/34 (20.6%) | 9 |
Serum calcium decreased | 7/34 (20.6%) | 9 |
Serum glucose decreased | 1/34 (2.9%) | 1 |
Serum magnesium decreased | 4/34 (11.8%) | 7 |
Serum magnesium increased | 1/34 (2.9%) | 1 |
Serum phosphate decreased | 2/34 (5.9%) | 3 |
Serum potassium decreased | 2/34 (5.9%) | 4 |
Serum potassium increased | 3/34 (8.8%) | 3 |
Serum sodium decreased | 6/34 (17.6%) | 10 |
Serum sodium increased | 1/34 (2.9%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Muscle weakness | 2/34 (5.9%) | 4 |
Muscle weakness lower limb | 1/34 (2.9%) | 1 |
Musculoskeletal disorder | 2/34 (5.9%) | 4 |
Nervous system disorders | ||
Dizziness | 1/34 (2.9%) | 1 |
Headache | 3/34 (8.8%) | 3 |
Intracranial hemorrhage | 1/34 (2.9%) | 1 |
Tremor | 2/34 (5.9%) | 2 |
Psychiatric disorders | ||
Anxiety | 2/34 (5.9%) | 2 |
Confusion | 1/34 (2.9%) | 1 |
Insomnia | 1/34 (2.9%) | 1 |
Personality change | 1/34 (2.9%) | 1 |
Renal and urinary disorders | ||
Renal failure | 4/34 (11.8%) | 4 |
Reproductive system and breast disorders | ||
Erectile dysfunction | 1/34 (2.9%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 1/34 (2.9%) | 1 |
Dyspnea | 3/34 (8.8%) | 4 |
Hypoxia | 3/34 (8.8%) | 3 |
Pleural effusion | 1/34 (2.9%) | 2 |
Pneumonitis | 1/34 (2.9%) | 1 |
Voice alteration | 1/34 (2.9%) | 1 |
Skin and subcutaneous tissue disorders | ||
Dry skin | 1/34 (2.9%) | 1 |
Pruritus | 2/34 (5.9%) | 3 |
Rash desquamating | 2/34 (5.9%) | 3 |
Skin disorder | 1/34 (2.9%) | 1 |
Vascular disorders | ||
Hypertension | 1/34 (2.9%) | 3 |
Hypotension | 3/34 (8.8%) | 3 |
Thrombosis | 2/34 (5.9%) | 2 |
Other (Not Including Serious) Adverse Events |
||
Pentostatin | ||
Affected / at Risk (%) | # Events | |
Total | 30/34 (88.2%) | |
Blood and lymphatic system disorders | ||
Hemoglobin decreased | 15/34 (44.1%) | 67 |
Cardiac disorders | ||
Arrhythmia supraventricular | 1/34 (2.9%) | 2 |
Atrial fibrillation | 1/34 (2.9%) | 2 |
Cardiac disorder | 3/34 (8.8%) | 6 |
Edema | 3/34 (8.8%) | 13 |
Myocardial ischemia | 1/34 (2.9%) | 1 |
Sinus tachycardia | 4/34 (11.8%) | 15 |
Endocrine disorders | ||
Cushingoid | 1/34 (2.9%) | 8 |
Eye disorders | ||
Cataract | 1/34 (2.9%) | 1 |
Dry eye syndrome | 5/34 (14.7%) | 19 |
Extraocular muscle paresis | 1/34 (2.9%) | 2 |
Eye disorder | 2/34 (5.9%) | 4 |
Eye pain | 1/34 (2.9%) | 2 |
Glaucoma | 1/34 (2.9%) | 1 |
Photophobia | 3/34 (8.8%) | 10 |
Vision blurred | 4/34 (11.8%) | 5 |
Gastrointestinal disorders | ||
Abdominal distension | 1/34 (2.9%) | 1 |
Abdominal pain | 1/34 (2.9%) | 2 |
Constipation | 6/34 (17.6%) | 20 |
Diarrhea | 9/34 (26.5%) | 13 |
Dry mouth | 5/34 (14.7%) | 10 |
Dyspepsia | 1/34 (2.9%) | 4 |
Dysphagia | 3/34 (8.8%) | 5 |
Ear, nose and throat examination abnormal | 3/34 (8.8%) | 7 |
Esophageal stenosis | 1/34 (2.9%) | 1 |
Esophagitis | 3/34 (8.8%) | 6 |
Mucositis oral | 1/34 (2.9%) | 3 |
Nausea | 11/34 (32.4%) | 22 |
Oral pain | 1/34 (2.9%) | 1 |
Vomiting | 4/34 (11.8%) | 9 |
General disorders | ||
Chest pain | 1/34 (2.9%) | 1 |
Chills | 2/34 (5.9%) | 2 |
Edema limbs | 3/34 (8.8%) | 6 |
Fatigue | 12/34 (35.3%) | 33 |
Fever | 3/34 (8.8%) | 4 |
Gait abnormal | 1/34 (2.9%) | 1 |
General symptom | 2/34 (5.9%) | 3 |
Ill-defined disorder | 1/34 (2.9%) | 1 |
Pain | 7/34 (20.6%) | 23 |
Hepatobiliary disorders | ||
Hepatic failure | 1/34 (2.9%) | 1 |
Hepatobiliary disease | 2/34 (5.9%) | 3 |
Immune system disorders | ||
Hypersensitivity | 1/34 (2.9%) | 1 |
Immune system disorder | 1/34 (2.9%) | 5 |
Infections and infestations | ||
Bladder infection | 2/34 (5.9%) | 2 |
Infection | 2/34 (5.9%) | 2 |
Infection without neutropenia | 4/34 (11.8%) | 6 |
Opportunistic infection | 1/34 (2.9%) | 1 |
Otitis media | 1/34 (2.9%) | 1 |
Pneumonia | 3/34 (8.8%) | 3 |
Skin infection | 1/34 (2.9%) | 3 |
Tooth infection | 1/34 (2.9%) | 2 |
Upper respiratory infection | 3/34 (8.8%) | 7 |
Ureteritis | 1/34 (2.9%) | 2 |
Urinary tract infection | 1/34 (2.9%) | 1 |
Wound infection | 1/34 (2.9%) | 1 |
Injury, poisoning and procedural complications | ||
Bruising | 1/34 (2.9%) | 1 |
Investigations | ||
Activated partial thromboplastin time prolonged | 1/34 (2.9%) | 1 |
Alanine aminotransferase increased | 20/34 (58.8%) | 61 |
Alkaline phosphatase | 7/34 (20.6%) | 27 |
Alkaline phosphatase increased | 7/34 (20.6%) | 16 |
Aspartate aminotransferase increased | 20/34 (58.8%) | 72 |
Bilirubin associated with graft versus host disease (GVHD) for BMT studies | 1/34 (2.9%) | 1 |
Blood bilirubin increased | 6/34 (17.6%) | 10 |
Creatinine increased | 10/34 (29.4%) | 23 |
Gamma-glutamyltransferase increased | 1/34 (2.9%) | 4 |
INR increased | 1/34 (2.9%) | 1 |
Laboratory test abnormal | 6/34 (17.6%) | 27 |
Leukocyte count decreased | 11/34 (32.4%) | 28 |
Lymphocyte count decreased | 5/34 (14.7%) | 27 |
Neutrophil count decreased | 7/34 (20.6%) | 15 |
Platelet count decreased | 15/34 (44.1%) | 46 |
Serum cholesterol increased | 4/34 (11.8%) | 4 |
Weight loss | 3/34 (8.8%) | 6 |
Metabolism and nutrition disorders | ||
Acidosis | 1/34 (2.9%) | 1 |
Alkalosis | 1/34 (2.9%) | 1 |
Anorexia | 3/34 (8.8%) | 6 |
Blood bicarbonate decreased | 3/34 (8.8%) | 5 |
Blood glucose increased | 15/34 (44.1%) | 71 |
Dehydration | 2/34 (5.9%) | 3 |
Iron overload | 1/34 (2.9%) | 3 |
Serum albumin decreased | 6/34 (17.6%) | 11 |
Serum calcium decreased | 10/34 (29.4%) | 13 |
Serum calcium increased | 2/34 (5.9%) | 5 |
Serum glucose decreased | 4/34 (11.8%) | 6 |
Serum magnesium decreased | 4/34 (11.8%) | 8 |
Serum magnesium increased | 2/34 (5.9%) | 4 |
Serum phosphate decreased | 3/34 (8.8%) | 7 |
Serum potassium decreased | 5/34 (14.7%) | 6 |
Serum potassium increased | 5/34 (14.7%) | 13 |
Serum sodium decreased | 11/34 (32.4%) | 18 |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 2/34 (5.9%) | 5 |
Back pain | 2/34 (5.9%) | 3 |
Bone pain | 2/34 (5.9%) | 2 |
Joint disorder | 2/34 (5.9%) | 5 |
Muscle weakness | 2/34 (5.9%) | 4 |
Muscle weakness lower limb | 3/34 (8.8%) | 6 |
Musculoskeletal disorder | 5/34 (14.7%) | 5 |
Myositis | 1/34 (2.9%) | 1 |
Pain in extremity | 2/34 (5.9%) | 6 |
Nervous system disorders | ||
Ataxia | 1/34 (2.9%) | 1 |
Cognitive disturbance | 1/34 (2.9%) | 1 |
Depressed level of consciousness | 1/34 (2.9%) | 3 |
Dizziness | 2/34 (5.9%) | 2 |
Headache | 2/34 (5.9%) | 5 |
Neurological disorder NOS | 2/34 (5.9%) | 2 |
Peripheral motor neuropathy | 3/34 (8.8%) | 4 |
Peripheral sensory neuropathy | 3/34 (8.8%) | 11 |
Tremor | 1/34 (2.9%) | 1 |
Psychiatric disorders | ||
Anxiety | 1/34 (2.9%) | 12 |
Confusion | 1/34 (2.9%) | 1 |
Depression | 3/34 (8.8%) | 7 |
Insomnia | 2/34 (5.9%) | 3 |
Renal and urinary disorders | ||
Glomerular filtration rate decreased | 1/34 (2.9%) | 1 |
Proteinuria | 1/34 (2.9%) | 2 |
Renal failure | 1/34 (2.9%) | 1 |
Urogenital disorder | 1/34 (2.9%) | 4 |
Reproductive system and breast disorders | ||
Erectile dysfunction | 1/34 (2.9%) | 3 |
Pelvic pain | 1/34 (2.9%) | 1 |
Reproductive tract disorder | 1/34 (2.9%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Allergic rhinitis | 1/34 (2.9%) | 1 |
Aspiration | 1/34 (2.9%) | 1 |
Cough | 4/34 (11.8%) | 6 |
Dyspnea | 9/34 (26.5%) | 16 |
Epistaxis | 1/34 (2.9%) | 2 |
Hypoxia | 1/34 (2.9%) | 1 |
Pleural effusion | 3/34 (8.8%) | 5 |
Pleuritic pain | 1/34 (2.9%) | 1 |
Skin and subcutaneous tissue disorders | ||
Alopecia | 1/34 (2.9%) | 10 |
Dry skin | 3/34 (8.8%) | 6 |
Erythema multiforme | 1/34 (2.9%) | 1 |
Nail disorder | 1/34 (2.9%) | 2 |
Pain of skin | 2/34 (5.9%) | 6 |
Pruritus | 1/34 (2.9%) | 5 |
Rash desquamating | 11/34 (32.4%) | 63 |
Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies | 1/34 (2.9%) | 1 |
Skin disorder | 4/34 (11.8%) | 20 |
Skin hyperpigmentation | 1/34 (2.9%) | 2 |
Skin ulceration | 1/34 (2.9%) | 2 |
Sweating | 1/34 (2.9%) | 1 |
Vascular disorders | ||
Flushing | 1/34 (2.9%) | 1 |
Hypertension | 4/34 (11.8%) | 8 |
Hypotension | 1/34 (2.9%) | 1 |
Thrombosis | 1/34 (2.9%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Sherif S. Farag, M.D., Ph.D. |
---|---|
Organization | The Ohio State University Medical Center |
Phone | |
farag-1@medctr.osu.edu |
- CALGB-100101
- U10CA031946
- CDR0000341678