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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors Clinical research trials and Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors  Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
For Condition: recurrent testicular cancer,recurrent ovarian germ cell tumor,extragonadal germ cell tumor
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, ifosfamide, carboplatin and etoposide plus peripheral stem cell transplantation in treating patients who have cisplatin-resistant advanced germ cell tumors.
Details: OBJECTIVES: - Determine the safety of paclitaxel and ifosfamide followed by carboplatin and etoposide with stem cell support in patients with unfavorable germ cell tumors with unfavorable prognostic factors and resistance to cisplatin. - Determine the efficacy of this regimen as salvage therapy in these patients. - Escalate the dose of carboplatin based on a target area under the concentration time curve and renal function, and determine the pharmacokinetics of carboplatin in selected patients. - Determine the qualitative effects of paclitaxel and ifosfamide on hematopoietic progenitors in these patients. OUTLINE: This is a dose escalation study of carboplatin. Patients are treated on regimen A followed by regimen B. - Regimen A: Patients receive paclitaxel IV continuously on day 1 and ifosfamide IV over 4 hours on days 2-4. Autologous peripheral blood stem cells (PBSC) are harvested on days 11-13. Filgrastim (G-CSF) is administered subcutaneously (SC) twice daily beginning 6 hours after completion of paclitaxel and ifosfamide infusions and continuing until the last day of leukapheresis. Treatment continues every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Before beginning the first course of chemotherapy, autologous bone marrow (ABM) is harvested, if possible, in case insufficient peripheral blood stem cells (PBSC) are harvested. Patients who were unable to undergo harvest of ABM before the first course of chemotherapy undergo harvest of ABM before beginning the second course of chemotherapy. - Beginning 2 weeks after completion of regimen A, patients receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. PBSC are reinfused on day 5. G-CSF is administered SC twice daily beginning 6 hours after completion of etoposide and carboplatin infusions and continuing until blood counts recover. G-CSF is held on the morning of PBSC transplantation and restarted beginning 6 hours after completion of PBSC transplantation. Treatment continues every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with insufficient PBSC for the second course receive PBSC combined with ABM. Patients with insufficient PBSC for the third course receive ABM. During regimen B, cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. After completion of regimens A and B, some patients may undergo resection of residual masses. PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven advanced germ cell tumor that is resistant to a cisplatin-based chemotherapy regimen - Must meet 1 of the following conditions: - Measurable or evaluable disease - Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin) - Known residual disease after postchemotherapy surgery - Unfavorable prognostic factors for achieving a complete response to cisplatin-based salvage therapy required, including either: - Extragonadal primary site OR - Testis/ovarian primary with incomplete response to first-line therapy - No marrow involvement with tumor on pretherapy bone marrow aspiration and biopsy - Marrow must be normocellular PATIENT CHARACTERISTICS: Age: - 14 and over Performance status: - Not specified Hematopoietic: - WBC at least 3,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Not specified Renal: - Creatinine clearance greater than 50 mL/min - Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator Cardiovascular: - If history of significant cardiac disease, evaluation and clearance by a cardiologist required before study entry Other: - HIV negative - No active infection - General medical condition sufficient to allow general anesthesia at the time of marrow harvest PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior autologous bone marrow transplantation with high-dose therapy Chemotherapy: - See Disease Characteristics - No more than 5 prior courses (4 preferred) of cisplatin - At least 3 weeks since prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics - Recovered from recent surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMotzer, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Robert Motzer 646-422-4312
Additional Information:
Study ID Numbers: CDR0000063449; MSKCC-93162,NCI-V94-0407
Study Start Date:
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002558
Other Recurrent Testicular Cancer Studies:
1. Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
2. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
3. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
4. Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
5. Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
Related Studies:
Other recurrent testicular cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
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