Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase I | Treatment | Closed | Over 18 | NCI | YALE-HIC-9042 NCI-G97-1155, NCT00002948 |
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.
Entry Criteria
Disease Characteristics:
- Histologically confirmed refractory malignancies for which no effective therapy is currently available
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
Patient Characteristics:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count at least 100,000/mm3
- Absolute neutrophil count at least 1,500/mm3
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
Expected Enrollment
Not specified
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.
Trial Lead Organizations
Yale Cancer Center
 | | | |
| Mario Sznol, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | A Phase I Study of High Dose Topotecan with Filgrastim and Peripheral Blood Stem Cell Support for Patients with Refractory Malignancies | |
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| Trial Start Date | 1996-10-17 | |
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| Registered in ClinicalTrials.gov | NCT00002948 | |
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| Date Submitted to PDQ | 1996-10-17 | |
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| Information Last Verified | 2006-08-16 | |
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| NCI Grant/Contract Number | CA16359 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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