Gemcitabine in Treating Children With Refractory Solid Tumors - Full Text View

Sponsor:	Children's Cancer Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005577

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors.

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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

Study Start Date:

August 1996

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.

PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study over 18 months.

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 Hematopoietic: 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) Hepatic: Bilirubin no greater than 1.5 times normal AST less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope GFR at least 70 mL/min Other: No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic: At least 2 weeks since prior cytokine therapy and recovered No prior bone marrow transplantation Chemotherapy: No more than 3 prior combination or single agent chemotherapy regimens At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Contacts and Locations

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

Show 23 Study Locations

Sponsors and Collaborators

Children's Cancer Group

National Cancer Institute (NCI)

Investigators

Study Chair:

John S. Holcenberg, MD

Seattle Children's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00005577 History of Changes
Other Study ID Numbers:	CDR0000064886, CCG-0954
Study First Received:	May 2, 2000
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012