A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mario Sznol, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Yale University
Authority:
United States: Federal Government
Study ID:
CDR0000065416
NCT ID:
NCT00002948
Start Date:
October 1996
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
