Gemcitabine in Treating Children With Refractory Solid Tumors

NCT00005577 | Completed Phase 1

• 3 other identifiers: NCI-2012-02246CCG-0954CDR0000064886
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 23

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.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

gemcitabine hydrochloride DRUG

Arm I

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (23)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Cancer Center and Beckman Research Institute, City of Hope

Los Angeles, California, 91010-3000, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• John S. Holcenberg, MD

  Seattle Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: April 2, 2004
• Study Start: August 1, 1996
• Primary Completion: September 1, 2002
• Last Updated: February 5, 2013

Record last verified: 2002-12

Locations

AU (1); US (22)