NCT00365768

Brief Summary

RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine. PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

July 1, 2016

Enrollment Period

7.7 years

First QC Date

August 16, 2006

Results QC Date

November 6, 2015

Last Update Submit

July 25, 2016

Conditions

Kidney CancerLeukemiaLymphomaNeurotoxicityPeripheral NeuropathySarcoma

Keywords

stage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage II childhood small noncleaved cell lymphomastage I Wilms tumorstage II Wilms tumorstage III Wilms tumorstage IV Wilms tumorstage V Wilms tumorchildhood grade III lymphomatoid granulomatosischildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomastage I childhood large cell lymphomastage I childhood lymphoblastic lymphomastage I childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomastage IV childhood lymphoblastic lymphomastage IV childhood small noncleaved cell lymphomachildhood Burkitt lymphomastage III childhood small noncleaved cell lymphomauntreated childhood acute lymphoblastic leukemiachildhood nasal type extranodal NK/T-cell lymphomapreviously untreated childhood rhabdomyosarcomalocalized Ewing sarcoma/PNETmetastatic Ewing sarcoma/PNETneurotoxicityperipheral neuropathy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Vincristine-induced Peripheral Neuropathy

    Up to 30 weeks from baseline while on Vincristine treatment

Secondary Outcomes (1)

  • Number of Participants With Progression of Neuropathy

    42 days

Study Arms (2)

Arm I: Glutamine

EXPERIMENTAL

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

Drug: Glutamine

Arm II: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

GlutamineDRUG

Administered orally twice daily for 21 days

Also known as: Nutritional Supplement
Arm I: Glutamine
PlaceboOTHER

Administered orally twice daily for 21 days

Arm II: Placebo

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsLeukemiaLymphomaNeurotoxicity SyndromesPeripheral Nervous System DiseasesSarcomaBurkitt LymphomaWilms TumorLymphoma, Large B-Cell, DiffuseDendritic Cell Sarcoma, InterdigitatingLymphoma, Extranodal NK-T-CellNeuroectodermal Tumors, Primitive, Peripheral

Interventions

GlutamineDietary Supplements

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNervous System DiseasesPoisoningChemically-Induced DisordersNeuromuscular DiseasesNeoplasms, Connective and Soft TissueEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, NeutralFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Julia Glade-Bender, MD
Organization
Columbia University Medical Center
jg589@cumc.columbia.edu
212-305-3379

Study Officials

  • Julia L. Glade-Bender, MD

    Herbert Irving Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Irving Assistant Professor of Clinical Pediatrics

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

October 1, 2004

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 9, 2016

Results First Posted

September 9, 2016

Record last verified: 2016-07

Locations

US(1)