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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00002948

First received: November 1, 1999

Last updated: February 6, 2009

Last verified: August 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

October 1996

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00002948 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Biological: filgrastim
Drug: topotecan hydrochloride
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00002948

Other Study ID Numbers ^ICMJE

CDR0000065416, YALE-HIC-9042, NCI-G97-1155

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Mario Sznol, MD

Yale University

Information Provided By

National Cancer Institute (NCI)

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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