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Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission 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 Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission Clinical research trials and Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission 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 Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission 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 Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission clinical trial. Participants frequently get the best healthcare available for their Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission 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 > "M" Clinical Trials Conditions > Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission  Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
For Condition: ovarian clear cell cystadenocarcinoma,recurrent ovarian epithelial cancer,ovarian endometrioid adenocarcinoma,ovarian mixed epithelial carcinoma,stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,ovarian serous cystadenocarcinoma,ovarian mucinous cystadenocarcinoma,ovarian undifferentiated adenocarcinoma,Brenner Tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
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 chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa followed by peripheral stem cell transplantation in treating patients with stage III or stage IV epithelial ovarian cancer in complete remission.
Details: OBJECTIVES: I. Assess the toxic effects of combined high dose melphalan and thiotepa chemotherapy followed by stem cell rescue in patients with stage III or IV ovarian epithelial cancer in complete remission. II. Determine the maximum tolerated dose of thiotepa that can be given with melphalan in these patients. III. Evaluate the interpatient blood level variability and pharmacokinetics of melphalan given intravenously. PROTOCOL OUTLINE: This is a dose escalation study of thiotepa. Patients receive cytoreduction and mobilization of peripheral blood stem cells (PBSC) with filgrastim (G-CSF) and cyclophosphamide/paclitaxel, cyclophosphamide/etoposide or cyclophosphamide/etoposide/cisplatin within 30-90 days of last dose of standard therapy. PBSC are then collected. Patients then receive melphalan IV over 30 minutes on days -6 and -5 and thiotepa IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. G-CSF is administered on days 0-21. Cohorts of 5-15 patients each receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is reached. The MTD is determined as the dose at which 2-5 of 4-15 patients experience dose limiting toxicity. Patients are followed at 100 days, then at 6, 12, and 24 months. PROJECTED ACCRUAL: A total of 30-45 patients will be accrued for this study over 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III/IV ovarian epithelial cancer in first or second clinical complete remission after receiving a minimum of 4-10 courses of chemotherapy consisting of paclitaxel and either cisplatin or carboplatin - Ovarian epithelial cancer of following histologic types: Serous adenocarcinoma; Mucinous adenocarcinoma; Clear cell adenocarcinoma; Transitional cell; Adenocarcinoma N.O.S.; Endometrioid adenocarcinoma; Undifferentiated carcinoma; Mixed epithelial carcinoma; Malignant Brenner's Tumor - Remission stability maintained for at least 4 weeks - Protocol therapy must begin 30-90 days after last dose of standard therapy - No active pleural or pericardial effusion - No prior/concurrent brain metastasis or carcinoid meningitis --Prior/Concurrent Therapy-- - Biologic therapy: No prior stem cell transplant - Chemotherapy: Prior chemotherapy consisting of paclitaxel and either cisplatin or carboplatin - Endocrine therapy: Not specified - Radiotherapy: No prior radiation therapy for malignancy (excluding chest wall radiation therapy for breast cancer) - Surgery: Not specified --Patient Characteristics-- - Age: 18 to 60 - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin less than 1.5 times the upper limit of normal (ULN); SGOT or SGPT less than 2.0 times ULN; Albumin greater than 2.0 g/dL - Renal: Creatinine clearance greater than 60 mL/min - Cardiovascular: Ejection fraction greater than 45% by MUGA - Pulmonary: If history of smoking or abnormal lung function, Diffusion capacity greater than 50% (corrected); A-a gradient less than 20 - Other: No history of hemorrhagic cystitis; No second malignancy within the last 5 years except basal cell skin cancer; HIV negative; No chronic active hepatitis B; No hepatitis C; No history of Aspergillus infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonaHolmberg, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: CDR0000065499; FHCRC-1181.00,NCI-G97-1229
Study Start Date: January 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002977
Other Ovarian Endometrioid Adenocarcinoma Studies:
1. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
2. Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer
3. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
4. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
5. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
Related Studies:
Other ovarian endometrioid adenocarcinoma Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
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