Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
This study has been completed.
Sponsor:
University of South Florida
Collaborators:
Children's Oncology Group
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00369564
First received: August 24, 2006
Last updated: May 20, 2013
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Leukemia Lymphoma Neurotoxicity Peripheral Neuropathy Sarcoma |
Drug: glutamic acid Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Chronic Lymphocytic Leukemia
Constipation
Kidney Cancer
Leukemia
Lymphoma
Peripheral Nerve Disorders
Soft Tissue Sarcoma
Wilms' Tumor
U.S. FDA Resources
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- Neurotoxicity as measured by a scored neurologic examination at baseline, 5 weeks, and 10 weeks (if applicable) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- Frequency and types of neurotoxicity, including sensory neuropathy, motor neuropathy, laryngeal nerve, constipation/neuro-constipation, jaw pain, and other specific neurotoxicities [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 250 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I Glutamic Acid
Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
|
Drug: glutamic acid
Given orally 3 times daily
Other Name: l-glutamic acid hydrochloride
|
|
Placebo Comparator: Arm II Placebo
Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
|
Other: placebo
Given orally 3 times daily
|
Detailed Description:
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 250 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 3 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA:
- Patients ≥ 3 and < 21 years of age at the time of study registration.
- Patients newly diagnosed with Wilm's tumor and scheduled to receive at least 9 consecutive weeks of chemotherapy with a vincristine-containing regimen.
- Patients newly diagnosed with rhabdomyosarcoma and scheduled to receive at least 9 consecutive weeks of chemotherapy with a vincristine-containing regimen.
- Patients newly diagnosed with ALL and scheduled to receive 4 consecutive weeks of chemotherapy with a vincristine-containing regimen with accompanying steroid therapy.
- Patients newly diagnosed with NHL and scheduled to receive 4 consecutive weeks of chemotherapy with a vincristine-containing regimen with accompanying steroid therapy.
- Patients with no underlying neuromuscular disease or peripheral neuropathy
EXCLUSION CRITERIA:
- Abnormal baseline peripheral neurologic exam (i.e. or peripheral neuropathy)
- Patients with:
- seizure disorders
- primary intracranial malignancy
- family history of Charcot Marie Tooth Disease
- a recent history of GuillianBarré26
- Patients receiving concomitant itraconazole are at risk for increased vincristine toxicity and therefore are ineligible.
- Patients who are regularly using laxatives or stool softeners for constipation at the time of enrollment are not eligible to participate in the study. Likewise, since prevention of neuro-constipation will be evaluated, patients with an ongoing history of constipation that has required frequent use of laxatives or stool softeners should not be enrolled.
- Patients should not be scheduled to receive laxatives or stool softeners prophylactically to prevent constipation, as the prevention of neuro-constipation will be evaluated in this study; however, when patients show signs of developing constipation while on chemotherapy, as determined by the treating physician, they may be treated with laxatives or stool softeners at the clinician's discretion. Use of laxatives or stool softeners will be documented on the concomitant medication log.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369564
Locations
| United States, Florida | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| United States, Michigan | |
| Butterworth Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| United States, Ohio | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
Sponsors and Collaborators
University of South Florida
Children's Oncology Group
Investigators
| Study Chair: | Scott Bradfield, MD | Nemours Children's Clinic |
| Study Chair: | Eric Sandler, MD | Nemours Children's Clinic |
| Study Chair: | David R. Freyer, DO, MS | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00369564 History of Changes |
| Other Study ID Numbers: | SCUSF 0402, SCUSF 0402, ACCL 0731, 5U10CA081920-11 |
| Study First Received: | August 24, 2006 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Data and Safety Monitoring Board United States: Federal Government |
Keywords provided by University of South Florida:
|
neurotoxicity peripheral neuropathy stage I Wilms tumor stage II Wilms tumor stage III Wilms tumor stage IV Wilms tumor stage V Wilms tumor previously untreated childhood rhabdomyosarcoma childhood grade III lymphomatoid granulomatosis childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma stage I childhood large cell lymphoma stage II childhood large cell lymphoma |
stage III childhood large cell lymphoma stage IV childhood large cell lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma childhood Burkitt lymphoma stage I childhood small noncleaved cell lymphoma stage II childhood small noncleaved cell lymphoma stage III childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma untreated childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Leukemia Lymphoma Peripheral Nervous System Diseases Lymphoma, Non-Hodgkin Neurotoxicity Syndromes Sarcoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neuromuscular Diseases Nervous System Diseases Poisoning Substance-Related Disorders Neoplasms, Connective and Soft Tissue Vincristine Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 22, 2013