High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer

NCT00002948 | Terminated Phase 1

• 3 other identifiers: CDR0000065416YALE-HIC-9042NCI-G97-1155
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem cell transplantation in treating patients with refractory cancer.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

filgrastim BIOLOGICAL

topotecan hydrochloride DRUG

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed refractory malignancies for which no effective therapy is currently available PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 Hepatic: * Total bilirubin no greater than 2.0 mg/dL * No chronic active hepatitis Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * Left ventricular ejection fraction greater than 45% Pulmonary: * DLCO greater than 60% of predicted Other: * HIV negative * No active infection * No concurrent medical condition that would preclude therapy * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) Endocrine therapy: * Not specified Radiotherapy: * No radiotherapy to greater than 30% of bone marrow * No wide field radiotherapy Surgery: * Recovered from any prior surgery

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

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8032, United States

Location

MeSH Terms

Interventions

Filgrastim; Topotecan; Peripheral Blood Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Camptothecin; Alkaloids; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Mario Sznol, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: October 1, 1996
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: July 2, 2014

Record last verified: 2014-07

Locations

US (1)