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Gemcitabine in Treating Children With Refractory Solid Tumors

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00005577
Collaborator
(none)
30
Enrollment
23
Locations
1
Arm
1.3
Patients Per Site

Study Details

Study Description

Brief Summary

Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Condition or Disease Intervention/Treatment Phase
  • Drug: gemcitabine hydrochloride
 Phase 1

Detailed Description

OBJECTIVES:

  1. Estimate the maximum tolerated dose of gemcitabine in children and adolescents with refractory solid tumors.

  2. Assess the toxicity of gemcitabine in this patient population. III. Determine the pharmacokinetic profile of gemcitabine in male and female children and adolescents.

  3. Assess the antitumor activity of gemcitabine within a phase I study.

OUTLINE: This is a dose escalation study.

Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at week 4 and then every 6 months until death.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS
Study Start Date :
Aug 1, 1996
Actual Primary Completion Date :
Sep 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Drug: gemcitabine hydrochloride

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed malignant solid tumor Confirmation made at original diagnosis

    • No bone marrow involvement

    • Refractory to conventional therapy and other therapies of higher priority according to CCG Phase I/II Priority List

    PATIENT CHARACTERISTICS:

    • Age: 1 to 21

    • Performance status: 0-2

    • Life expectancy: At least 2 months

    • Absolute neutrophil count at least 1,000/mm3

    • Platelet count at least 100,000/mm3 (transfusion independent)

    • Hemoglobin at least 10 g/dL (transfusions allowed)

    • Bilirubin no greater than 1.5 times normal

    • AST less than 2.5 times normal

    • Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope GFR at least 70 mL/min

    • No seizure disorder Not pregnant or nursing

    • Negative pregnancy test Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:

    • At least 2 weeks since prior cytokine therapy and recovered

    • No prior bone marrow transplantation

    • No more than 3 prior combination or single agent chemotherapy regimens

    • At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Los Angeles Los Angeles California United States 90027-0700
    2 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    3 Cancer Center and Beckman Research Institute, City of Hope Los Angeles California United States 91010-3000
    4 Children's Hospital of Orange County Orange California United States 92868
    5 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    6 Children's National Medical Center Washington District of Columbia United States 20010-2970
    7 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    8 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    9 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    10 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    11 Children's Mercy Hospital Kansas City Missouri United States 64108
    12 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    13 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    14 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    15 Children's Hospital Medical Center - Cincinnati Cincinnati Ohio United States 45229-3039
    16 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    17 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    18 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    19 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    20 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    21 Children's Hospital and Regional Medical Center - Seattle Seattle Washington United States 98105
    22 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
    23 Princess Margaret Hospital for Children Perth Western Australia Australia 6001

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: John S. Holcenberg, MD, Seattle Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00005577
    Other Study ID Numbers:
    • NCI-2012-02246
    • CCG-0954
    • CDR0000064886
    First Posted:
    Apr 2, 2004
    Last Update Posted:
    Feb 5, 2013
    Last Verified:
    Dec 1, 2002
    Keywords provided by National Cancer Institute (NCI)
    unspecified childhood solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of Feb 5, 2013