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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00002948
First received: November 1, 1999
Last updated: July 1, 2014
Last verified: July 2014
  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
Biological: filgrastim
Drug: topotecan hydrochloride
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Yale University:

Study Start Date: October 1996
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Mario Sznol, MD Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00002948     History of Changes
Other Study ID Numbers: CDR0000065416, YALE-HIC-9042, NCI-G97-1155
Study First Received: November 1, 1999
Last Updated: July 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Topotecan
Lenograstim
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014