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Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer Clinical research trials and Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer. Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer  Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer,Male Breast Cancer
Status: No longer recruiting
Sponsor(s): Yale Cancer 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 kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of sequential high-dose chemotherapy followed by peripheral stem cell transplantation in treating patients with metastatic breast cancer that is responding to chemotherapy.
Details: OBJECTIVES: I. Evaluate the feasibility and efficacy of sequential high-dose cyclophosphamide, melphalan, and thiotepa followed by peripheral blood stem cell rescue in patients with metastatic breast cancer who show a continuing response to prior conventional-dose chemotherapy. PROTOCOL OUTLINE: All patients undergo peripheral blood stem cell (PBSC) collection using cyclophosphamide and granulocyte colony-stimulating factor (G-CSF). They then receive melphalan and thiotepa, each followed by PBSC re-infusion and G-CSF. Upon recovery from chemotherapy, patients with hormone receptor-positive tumors that are not refractory to hormonal therapy are treated with oral tamoxifen or megestrol. Patients may receive radiotherapy to prior bulky disease sites and/or undergo resection of residual lesions. Patients are followed weekly for 4 weeks, biweekly for 4 weeks, monthly for 6 months, then bimonthly for 1 year. PROJECTED ACCRUAL: A minimum of 30 patients will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically documented breast carcinoma that is stage IV and considered incurable by standard treatment; Pathology reviewed by Yale-New Haven Hospital Department of Pathology - Ongoing objective response to prior induction chemotherapy required - No brain metastasis - Hormone receptor status: Estrogen and progesterone status known --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior mitomycin or nitrosourea; At least 4 weeks since chemotherapy at time of stem cell harvest - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to pelvis or brain - Surgery: At least 2 weeks since major surgery --Patient Characteristics-- - Age: Over 18 - Sex: Women or men - Menopausal status: Not specified - Performance status: Karnofsky 80%-100% - Life expectancy: Greater than 3 months - Hematopoietic: ANC greater than 1,500; Platelets greater than 100,000; Hemoglobin greater than 9 g/dL - Hepatic: Bilirubin less than 1.5 times normal (unless benign congenital hyperbilirubinemia); PT and PTT normal; Liver biopsy normal if serologic evidence of active hepatitis B or C - Renal: Creatinine no greater than 1.2 mg/dL - Cardiovascular: No abnormal wall motion; No active heart disease; Left ventricular ejection fraction at least 50% - Pulmonary: DLCO normal - Other: Nutritional status adequate (greater than 1,000 calories/day orally); No HIV infection No other active serious medical or psychiatric disease; No other malignancy except: Basal cell skin carcinoma; In situ cervical cancer; Negative pregnancy test required of fertile women; Barrier method birth control required of fertile women throughout study and for up to 2 years thereafter
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraBurtness, Study Chair, Yale Cancer Center
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Additional Information:
Study ID Numbers: CDR0000064338; YALE-HIC-7372,NCI-V95-0721
Study Start Date: February 1994
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002680
Other Male Breast Cancer Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
2. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
3. Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer
4. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
5. Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
Related Studies:
Other Male Breast Cancer Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
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