Maximum Tolerated Dose of High Dose Topotecan with Filgrastim and Peripheral Blood Stem Cell Support for Refractory Malignancies
This study aims to determine the maximum tolerated dose of high dose Topotecan, when used with Filgrastim and Peripheral Blood Stem Cell support, for individuals with refractory malignancies.
filgrastim
+ topotecan hydrochloride
+ bone marrow ablation with stem cell support
Treatment Study
Summary
Study start date: October 1, 1996
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Yale Comprehensive Cancer Center
New Haven, United StatesOpen Yale Comprehensive Cancer Center in Google Maps