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
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: August 2006

November 1, 1999
February 6, 2009
October 1996
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Complete list of historical versions of study NCT00002948 on ClinicalTrials.gov Archive Site
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High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies

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.


  • 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.


Phase 1
Primary Purpose: Treatment
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
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  • Histologically confirmed refractory malignancies for which no effective therapy is currently available



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3


  • Total bilirubin no greater than 2.0 mg/dL
  • No chronic active hepatitis


  • Creatinine clearance at least 60 mL/min


  • Left ventricular ejection fraction greater than 45%


  • DLCO greater than 60% of predicted


  • HIV negative
  • No active infection
  • No concurrent medical condition that would preclude therapy
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin)

Endocrine therapy:

  • Not specified


  • No radiotherapy to greater than 30% of bone marrow
  • No wide field radiotherapy


  • Recovered from any prior surgery
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000065416, YALE-HIC-9042, NCI-G97-1155
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Yale University
National Cancer Institute (NCI)
Study Chair: Mario Sznol, MD Yale University
National Cancer Institute (NCI)
August 2006

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