Gemcitabine in Treating Children With Refractory Solid Tumors

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005577
• Other study ID #: NCI-2012-02246
• Secondary ID: CCG-0954CDR00000
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2000
• Last updated: February 4, 2013
• Start date: August 1996

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
Australia	Princess Margaret Hospital for Children	Perth	Western Australia
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Children's Hospital Medical Center - Cincinnati	Cincinnati	Ohio
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Cancer Center and Beckman Research Institute, City of Hope	Los Angeles	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,