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

Sponsors and Collaborators:	Yale University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002948

Purpose

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.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: filgrastim Drug: topotecan hydrochloride Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Filgrastim Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies

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

Study Start Date:

October 1996

Detailed Description:

OBJECTIVES:

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.

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.

PROJECTED ACCRUAL: Not specified

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002948

Locations

United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8032

Sponsors and Collaborators

Yale University

National Cancer Institute (NCI)

Investigators

Study Chair:

Mario Sznol, MD

Yale University

More Information

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

Study ID Numbers:	CDR0000065416, YALE-HIC-9042, NCI-G97-1155
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002948
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Topotecan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009