View Clinical Trial (Medical Research Study)
Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer [ACCL0731]
| City: |
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Columbus |
| State: |
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Ohio |
| Zip Code: |
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43205 |
| Conditions: |
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Kidney Cancer - Leukemia - Lymphoma - Neurotoxicity - Peripheral Neuropathy - Sarcoma |
| Purpose: |
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RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It
is not yet known whether glutamic acid is more effective than a placebo in preventing nerve
damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute
lymphoblastic leukemia, or non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works
compared to a placebo in reducing nerve damage caused by vincristine in young patients
receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or
non-Hodgkin's lymphoma.
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| Study Summary: |
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OBJECTIVES:
Primary
- Compare the effect of glutamic acid vs placebo, in terms of decreasing neurotoxicity as
measured by a scored neurologic examination, in young patients undergoing
vincristine-containing treatment for Wilms' tumor, rhabdomyosarcoma, acute
lymphoblastic leukemia, or non-Hodgkin's lymphoma.
Secondary
- Compare the frequency and types of neurotoxicity observed in patients treated with
glutamic acid versus placebo.
- Determine if a greater proportion of patients receiving glutamic acid are able to
receive 100% of their scheduled doses of vincristine versus those not treated with
glutamic acid.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to disease and duration of planned vincristine-containing treatment
(Wilms' tumor or rhabdomyosarcoma with treatment planned for ≥ 9 consecutive weeks [stratum
1] vs acute lymphoblastic leukemia or non-Hodgkin's lymphoma with treatment planned for ≥ 4
consecutive weeks [stratum 2]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral glutamic acid 3 times daily beginning prior to the first
dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of
vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.
- Arm II: Patients receive oral placebo 3 times daily beginning prior to the first dose
of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of
vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.
All patients undergo neurologic examination at baseline and at 5 weeks. Patients in stratum
1 also undergo additional neurologic examination at week 10.
PROJECTED ACCRUAL: A total of 208 patients will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Undergoing vincristine-containing treatment for any of the following newly diagnosed
malignancies:
- Wilms' tumor or rhabdomyosarcoma
- Scheduled to receive ≥ 9 consecutive weeks of vincristine-containing
chemotherapy regimen
- Acute lymphoblastic leukemia or non-Hodgkin's lymphoma
- Scheduled to receive ≥ 4 consecutive weeks of vincristine-containing
chemotherapy regimen and concurrent steroid therapy
- No underlying neuromuscular disease or peripheral neuropathy
- Normal baseline peripheral neurologic exam
- No primary intracranial malignancy
PATIENT CHARACTERISTICS:
- No seizure disorders
- No family history of Charcot-Marie-Tooth disease
- No recent history of Guillain-Barre syndrome
PRIOR CONCURRENT THERAPY:
- No concurrent itraconazole
- No regular use of laxatives or stool softeners prophylactically for constipation
prior to chemotherapy
- No concurrent enrollment on another investigational protocol involving a study agent
that is provided under an IND
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| NCT ID: |
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NCT00369564 |
| Primary Contact: |
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Study Chair
Scott Bradfield, MD
Nemours Children's Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbus, Ohio 43205
United States
Amanda M. Termuhlen, MD
Phone: 614-722-3572
Email: susan.cunningham@nationwidechildrens.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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