Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Over 18	NCI	YALE-HIC-9042 NCI-G97-1155, NCT00002948

Objectives

1. Determine the maximum tolerated dose, toxicities, and preliminary antitumor activity of escalating doses of topotecan, with filgrastim (G-CSF) and peripheral blood stem cell support, when administered to patients with refractory malignancies for which no effective therapy exists.

Entry Criteria

Disease Characteristics:

• Histologically confirmed refractory malignancies for which no effective therapy is currently available

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count at least 100,000/mm³
• Absolute neutrophil count at least 1,500/mm³

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

Expected Enrollment

Not specified

Outline

This is a dose-escalation study.

Prior to stem cell harvesting, patients receive 1-2 courses of mobilizing salvage chemotherapy.

After stem cell harvest, high-dose topotecan is administered according to an escalating dosage scale. Topotecan is given over 30 minutes daily for three days. A minimum of 3 patients are entered at each dose level. The MTD is defined as the dose immediately below that at which 2 patients experience dose limiting toxicity.

Peripheral blood stem cells (PBSC) are infused at least 24 hours after treatment with topotecan is complete. Filgrastim (G-CSF) is administered subcutaneously beginning on the day PBSC are infused and continuing until blood counts recover.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

Mario Sznol, MD, Protocol chair		Ph: 203-785-6221; 866-925-3226

Registry Information
Official Title		A Phase I Study of High Dose Topotecan with Filgrastim and Peripheral Blood Stem Cell Support for Patients with Refractory Malignancies
Trial Start Date		1996-10-17
Registered in ClinicalTrials.gov		NCT00002948
Date Submitted to PDQ		1996-10-17
Information Last Verified		2006-08-16
NCI Grant/Contract Number		CA16359

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