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

• Status: Terminated
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lenograstim; Topotecan

Criteria

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