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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Refractory or Recurrent Ovarian Cancer  Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Refractory or Recurrent Ovarian Cancer
Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Refractory or Recurrent Ovarian Cancer
For Condition: recurrent ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Loyola University ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide, carboplatin, mitoxantrone and autologous bone marrow transplantation in treating patients with refractory or recurrent ovarian cancer.
Details: OBJECTIVES: - Determine the response rate, duration of response, and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide, carboplatin, and mitoxantrone followed by autologous bone marrow transplantation. - Determine the nonhematopoietic toxicity of this regimen in these patients. OUTLINE: Autologous bone marrow is harvested before study entry. Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity. Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion. Patients are followed for survival. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.5-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of refractory or relapsed ovarian epithelial cancer - Must have failed prior regimen containing cisplatin or carboplatin - Bidimensionally measurable or evaluable disease - Serial CA-125 antigen titers or cytologically positive pleural effusion and/or ascites acceptable as evaluable disease - Autologous bone marrow harvest of greater than 1.2 x 10 to the eighth nucleated cells/kg required before study entry - No evidence of tumor at marrow harvest sites by bilateral bone marrow aspirates and biopsies, pelvic x-ray, and bone scan - CNS involvement allowed PATIENT CHARACTERISTICS: Age: - Under 65 Performance status: - SWOG 0-2 Life expectancy: - At least 8 weeks Hematopoietic: - WBC greater than 3,500/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10.0 g/dL Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT and SGPT less than 2 times upper limit of normal Renal: - Creatinine clearance greater than 60 mL/min - No prior hemorrhagic cystitis Cardiovascular: - LVEF greater than 45% by MUGA scan Other: - No hearing loss in voice tones - No active infection - No psychological contraindication to study treatment - Not pregnant - Negative pregnancy test - HIV negative - General medical condition must allow general anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior bone marrow transplantation - More than 4 weeks since other prior biologic therapy and recovered Chemotherapy: - See Disease Characteristics - More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - More than 4 weeks since prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickStiff, Study Chair, Loyola University
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
Additional Information:
Study ID Numbers: CDR0000076845; LUMC-3007,NCI-V91-0058
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002474
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
2. Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
3. Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer
4. Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
5. BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other Illinois Clinical Trials
Other Maywood Clinical Trials
Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Refractory or Recurrent Ovarian Cancer
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