Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients Receiving Vincristine for Wilms' Tumor, Rhabdomyosarcoma, Acute Lymphoblastic Leukemia, or Non-Hodgkin's Lymphoma



Status:Recruiting
Conditions:Cancer, Cancer, Blood Cancer, Lymphoma, Neurology, Kidney Cancer, Leukemia
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:3 - 20
Updated:3/30/2013
Start Date:May 2007

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Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer [ACCL0731]


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.


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.

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
We found this trial at
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100 Michigan St NE
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1201 Camino de Salud Northeast
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1405 Clifton Road Northeast
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2545 Schoenersville Rd
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1025 Morehead Medical Dr # 600
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700 Childrens Drive
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3533 South Alameda Street
Corpus Christi, Texas 78411
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1200 Pleasant Street
Des Moines, Iowa 50309
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9981 South Healthpark Drive
Fort Myers, Florida 33908
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2776 Cleveland Ave
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(239) 343-9500
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801 Seventh Avenue
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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1920 Libal Street
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30 Prospect Avenue
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1000 Joe DiMaggio Drive
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807 Childrens Way
Jacksonville, Florida 32207
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1800 West Charleston Boulevard
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701 E 28th St # 202
Long Beach, California 90806
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4650 Sunset Blvd
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425 E River Pkwy # 754
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2501 N Orange Ave # 235
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Pensacola, Florida 32504
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2801 North Gantebein Ave.
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501 6th Ave S
Saint Petersburg, Florida 33701
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1 Medical Center Blvd
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