Gemcitabine in Treating Children With Refractory Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005577
First received: May 2, 2000
Last updated: February 4, 2013
Last verified: December 2002
  Purpose

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 Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 30
Study Start Date: August 1996
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005577

  Show 23 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: John S. Holcenberg, MD Seattle Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005577     History of Changes
Other Study ID Numbers: NCI-2012-02246, CCG-0954, CDR0000064886
Study First Received: May 2, 2000
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014