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Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Clinical research trials and Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer  Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
For Condition: ovarian serous cystadenocarcinoma,ovarian clear cell cystadenocarcinoma,recurrent ovarian epithelial cancer,ovarian endometrioid adenocarcinoma,peritoneal cavity cancer,ovarian mixed epithelial carcinoma,ovarian mucinous cystadenocarcinoma,Fallopian Tube Cancer,ovarian undifferentiated adenocarcinoma
Status: Completed
Sponsor(s): Johns Hopkins Oncology Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation and peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell transplantation in treating patients who have advanced ovarian epithelial cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of carboplatin when combined with cyclophosphamide as high-dose therapy followed by autologous bone marrow and peripheral blood stem cell rescue in patients with platinum sensitive ovarian epithelial carcinoma. II. Determine the efficacy of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of carboplatin. Autologous bone marrow (ABM) is harvested on day -11, filgrastim (G-CSF) is administered subcutaneously (SC) on days -11 to -7, and autologous peripheral blood stem cells (PBSC) are harvested on day -6. Patients receive high dose chemotherapy comprising carboplatin IV over 15 minutes on days -5 and -4 and cyclophosphamide IV over 1 hour on days -3 and -2. PBSC are reinfused on day -1, ABM is reinfused on day 0, and G-CSF is administered SC beginning on day 7 and continuing until blood counts recover. Cohorts of 2-4 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. A minimum of 6 patients receive carboplatin at the MTD. Patients are followed at 1 month and then every 3 months for 5 years. PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced ovarian epithelial malignancy of one of the following histologies: Serous adenocarcinoma; Endometrioid adenocarcinoma; Mucinous adenocarcinoma; Undifferentiated carcinoma; Clear cell adenocarcinoma; Mixed epithelial carcinoma - Fallopian tube and extraovarian peritoneal papillary serous tumors also allowed - Documented responsiveness (using established clinical criteria) to a platinum-based chemotherapy regimen required - Partial or complete clinical response to the most recent chemotherapy regimen required - Bone marrow aspirate and biopsy morphologically negative for carcinoma and cellularity greater than 50% - No CNS involvement --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No more than 2 prior chemotherapy regimens; At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy for ovarian cancer - Surgery: Not specified --Patient Characteristics-- - Age: 18 to 65 - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC greater than 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL*; SGOT less than 60 IU/mL* * Unless abnormality due to metastatic involvement - Renal: Creatinine less than 2.0 mg/dL* * Unless abnormality due to metastatic involvement - Cardiovascular: LVEF at least 45% by MUGA scan; No active congestive heart failure; No myocardial infarction within the past year; No active arrhythmia; No active angina pectoris; No uncontrolled hypertension - Pulmonary: FVC and FEV at least 50% predicted - Other: No peripheral neuropathy; No uncontrolled diabetes mellitus; No history of other malignancy except basal cell or squamous cell skin cancer; No debilitating medical or psychiatric illness that would preclude informed consent or study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeborahArmstrong, Study Chair, Johns Hopkins Oncology Center
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: CDR0000063839; JHOC-9434,NCI-V94-0544
Study Start Date: September 1994
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002600
Other Peritoneal Cavity Cancer Studies:
1. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
2. Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
4. TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
5. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
Related Studies:
Other peritoneal cavity cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
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