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High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer Clinical research trials and High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer. High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer clinical trial. Participants frequently get the best healthcare available for their High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer  High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Yale Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnMurren, Study Chair, Yale Cancer Center
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8032
United States
Recruiting Barbara Burtness 203-737-5064
Additional Information:
Study ID Numbers: CDR0000065416; YALE-HIC-9042,NCI-G97-1155
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002948
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
2. Octreotide and Doxorubicin in Treating Patients With Advanced Cancer
3. Improving Pain Management in Patients With Nonhematologic Cancer
4. Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C
5. Geldanamycin Analogue in Treating Patients With Advanced Cancer
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High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
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