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A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS


Phase 1
1 Year
21 Years
Not Enrolling
Both
Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS


OBJECTIVES:

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

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

IV. 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John S. Holcenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Children's Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02246

NCT ID:

NCT00005577

Start Date:

August 1996

Completion Date:

Related Keywords:

  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105