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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer  Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
For Condition: inflammatory breast cancer,stage 3A breast cancer,stage 3B breast cancer,stage 4 breast cancer,stage 2 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
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 II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating women who have breast cancer.
Details: OBJECTIVES: I. Determine long term remission rates as measured by disease free survival in women with breast cancer treated with cyclophosphamide, thiotepa, and carboplatin followed by autologous hematopoietic stem cell transplantation. II. Determine the safety and efficacy of this combination chemotherapy regimen in this patient population. PROTOCOL OUTLINE: Peripheral blood stem cells (PBSC) are collected. Patients sequentially receive cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on days -6 to -4. PBSC are reinfused on day 0. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter. PROJECTED ACCRUAL: At least 40 patients with 4-9 positive lymph nodes and at least 50 patients with 10 positive lymph nodes will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed breast cancer; Stage II with greater than 3 positive axillary lymph nodes following standard induction chemotherapy, as well as surgery and/or radiation as clinically indicated; Stage III following standard induction chemotherapy with an anthracycline based regimen, and surgery and/or radiation as clinically indicated; Inflammatory carcinoma following standard induction chemotherapy with an anthracycline based regimen, and surgery and/or radiation as clinically indicated; Stage IV metastatic disease that has demonstrated a complete response to an anthracycline containing regimen, or no evidence of disease after surgery or radiation - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; Prior total dose of doxorubicin or daunorubicin less than 450 mg/m2 unless endometrial biopsy shows less than grade 2 drug effect - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics - Other: No concurrent nitroglycerin preparations for angina pectoris; No concurrent antiarrhythmic drugs for major ventricular dysrrhythmias --Patient Characteristics-- - Age: 64 and under - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT no greater than 2.5 times upper limit of normal; No history of severe hepatic dysfunction - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No evidence of severe cardiac dysfunction; Ejection fraction at least 50% by MUGA; No major heart disease; Essential hypertension controlled with medications allowed - Pulmonary: DLCO at least 50% of normal; No symptomatic obstructive or restrictive pulmonary disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No psychosocial disorder that would preclude study compliance; No concurrent active infections; No insulin dependent diabetes mellitus; No uncompensated major thyroid or adrenal dysfunction; No significant skin breakdown from tumor or other disease; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KarenFields, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Halifax Medical Center
Daytona Beach, Florida, 32114
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Additional Information:
Study ID Numbers: CDR0000067768; MCC-11072,NCI-G00-1760,MCC-IRB-3898
Study Start Date: July 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005798
Other Stage 4 Breast Cancer Studies:
1. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer
2. Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
3. Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
4. Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
5. Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Florida Clinical Trials
Other Ft. Myers Clinical Trials
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
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