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Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer


Phase 3
3 Years
20 Years
Not Enrolling
Both
Kidney Cancer, Leukemia, Lymphoma, Neurotoxicity, Peripheral Neuropathy, Sarcoma

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Trial Information

Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Neurotoxicity as measured by a scored neurologic examination at baseline, 5 weeks, and 10 weeks (if applicable)

Outcome Time Frame:

10 weeks

Safety Issue:

Yes

Principal Investigator

Scott Bradfield, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Nemours Children's Clinic

Authority:

United States: Food and Drug Administration

Study ID:

SCUSF 0402

NCT ID:

NCT00369564

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Neurotoxicity
  • Peripheral Neuropathy
  • Sarcoma
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Peripheral Nervous System Diseases
  • Lymphoma, Non-Hodgkin
  • Neurotoxicity Syndromes
  • Sarcoma

Name

Location

Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Nationwide Children's HospitalColumbus, Ohio  43205-2696