Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink or slow the growth of pediatric low-grade gliomas that have either returned or are continuing to grow.
Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its therapeutic spectrum and decrease the neurotoxicity associated with related agents.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerated, more effective treatments.
Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas. It has been fairly well tolerated in both adult and pediatric studies that have examined its use in other tumors.
Objective: To test the efficacy of Vinorelbine in children with pediatric low-grade glioma that has returned or continues to grow.
In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. The patients will then be followed for 60 months. Progression free survival is the primary outcome and defined as the none of the following: greater a 20% increase in the sun of the longest diameter of the target lesion, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vinorelbine IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months. |
Drug: Vinorelbine
IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival [Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.]
IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age: < 18 years
-
Tumor: Progressive or recurrent low grade glioma, WHO grade 1 or 2 who have failed at least one form of 'conventional' non-surgical therapy
-
Histologic confirmation is required with the exception of optic pathway and brain stem gliomas. Patients are not required to have a re-operation at time of recurrence.
-
Patients with disseminated disease are eligible.
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Children with neuro-fibromatosis and optic pathway or brainstem tumors are eligible but must have definitive radiologic or clinical evidence of progression
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Patients must have evidence of measureable disease
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Performance status: Karnofsky or Lansky performance status of >50%
-
Organ Function:
-
Adequate bone marrow function (ANC>1000/mm3, platelet count of >75,000/mm3, and hemoglobin > 8gm/dL) prior to starting therapy. Hemoglobin may be supported by transfusion
-
Adequate liver function (SGPT/ALT<2.5 times ULN and bilirubin < 1.5 times ULN) prior to starting therapy
-
Prior therapy:
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May have had treatment including surgery, chemotherapy, or radiotherapy for any number of relapses prior to enrollment
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Patients must have received their last fraction of radiotherapy >12 weeks prior to starting therapy
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Previous Vincristine or Vinblastine exposure is allowable.
Exclusion Criteria:
-
No other significant medical illness that in the investigators' opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
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Any other cancer (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
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Patients of childbearing potential must not be pregnant or breast-feeding (vinorelbine is a pregnancy category D, no data on excretion in breastmilk)
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Patients of childbearing or fathering potential must practice adequate contraception
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 2 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Eugene Hwang
Investigators
- Principal Investigator: Eugene Hwang, MD, Children's National Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CNMC-VRL
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vinorelbine |
|---|---|
| Arm/Group Description | Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months. |
| Period Title: Overall Study | |
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Vinorelbine |
|---|---|
| Arm/Group Description | Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months. Patients recruited without incidence over a 2 year period. |
| Overall Participants | 12 |
| Age (Count of Participants) | |
| <=18 years |
12
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Median (Standard Deviation) ] | |
| Median (Standard Deviation) [years] |
6.5
(3.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
6
50%
|
| Male |
6
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
12
100%
|
Outcome Measures
| Title | Progression-free Survival |
|---|---|
| Description | IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months. |
| Time Frame | Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vinorelbine |
|---|---|
| Arm/Group Description | IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months. Vinorelbine: IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months. |
| Measure Participants | 13 |
| Number (90% Confidence Interval) [percentage] |
23.1
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Adverse Events | |
| Arm/Group Description | Neutropenia - Grade 4 (n=2) Thrombocytopenia - Grade 4 (n=1) Anemia - Grade 3 (n=2) Weight Loss - grade 2 (n=1) | |
All Cause Mortality |
||
| Adverse Events | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Adverse Events | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Adverse Events | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/13 (46.2%) | |
| Blood and lymphatic system disorders | ||
| thrombocytopenia | 1/13 (7.7%) | 1 |
| neutropenia | 2/13 (15.4%) | 3 |
| anemia | 2/13 (15.4%) | 2 |
| General disorders | ||
| weight loss | 1/13 (7.7%) | 1 |
Limitations/Caveats
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 | Associate Professor |
|---|---|
| Organization | Children's National Medical Center |
| Phone | 2024765046 |
| ehwang@childrensnational.org |
- CNMC-VRL