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A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer


Phase 2
5 Years
21 Years
Not Enrolling
Both
Kidney Cancer, Leukemia, Lymphoma, Neurotoxicity, Peripheral Neuropathy, Sarcoma

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Trial Information

A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer


OBJECTIVES:

Primary

- Determine the incidence of vincristine-induced peripheral neuropathy in pediatric
patients with lymphoma, leukemia, or solid tumors.

Secondary

- Compare the safety of glutamine vs placebo in these patients.

- Compare the efficacy of glutamine vs placebo in reducing the progression and/or
resolution of vincristine-induced peripheral neuropathy in these patients.

- Compare the effect of glutamine supplementation vs placebo on chemotherapy-related
toxicities in these patients.

- Compare the effect of glutamine vs placebo on measures of quality of life in these
patients.

- Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor
and glutamine levels in these patients.

- Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.

OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients
receive oral glutamine twice daily on days 1-21.

- Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients
receive oral placebo twice daily on days 1-21.

Patients in both arms undergo neuropsychological and clinical neurological assessment, blood
collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and
quality of life assessment on days 1, 21, and 42.

After completion of study treatment, patients are followed for an additional 21 days.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.


Inclusion Criteria:



- Patients between the age of 5 and 21 years old.

- Patients who demonstrate the ability to complete the assessment instruments at
baseline.

- Patients who are diagnosed with leukemia or solid tumors and are expected to receive
a cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual
vincristine doses are capped at 2mg according to primary cancer treatment protocol,
over a 30-week period.

Exclusion Criteria:

- Patients with primary CNS tumors other than medulloblastoma or patients with CNS
metastasis.

- Patients with recurrent disease.

- Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on
clinical exam.

- Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual
vincristine doses are capped at 2mg according to primary cancer treatment protocol,
during their course of therapy at time of consent.

- Patients with hepatic encephalopathy or hyperammonemia.

- Patients with a focally abnormal neurologic exam.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of vincristine-induced peripheral neuropathy

Outcome Time Frame:

42 days

Safety Issue:

Yes

Principal Investigator

Julia L. Glade-Bender, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

AAAA6806

NCT ID:

NCT00365768

Start Date:

October 2004

Completion Date:

June 2012

Related Keywords:

  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Neurotoxicity
  • Peripheral Neuropathy
  • Sarcoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage I Wilms tumor
  • stage II Wilms tumor
  • stage III Wilms tumor
  • stage IV Wilms tumor
  • stage V Wilms tumor
  • childhood grade III lymphomatoid granulomatosis
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • stage I childhood large cell lymphoma
  • stage I childhood lymphoblastic lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • childhood Burkitt lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • untreated childhood acute lymphoblastic leukemia
  • childhood nasal type extranodal NK/T-cell lymphoma
  • previously untreated childhood rhabdomyosarcoma
  • localized Ewing sarcoma/PNET
  • metastatic Ewing sarcoma/PNET
  • neurotoxicity
  • peripheral neuropathy
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Peripheral Nervous System Diseases
  • Lymphoma, Non-Hodgkin
  • Neurotoxicity Syndromes
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Sarcoma

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032