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Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer Clinical research trials and Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer. Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer  Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
For Condition: stage 3B breast cancer,inflammatory breast cancer,recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
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. Interleukin-2 and colony-stimulating factors such as sargramostim may help a person's immune system kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation followed by interleukin-2 and sargramostim in treating patients who have inflammatory stage IIIB or metastatic stage IV breast cancer.
Details: OBJECTIVES: - Determine the event-free survival of patients treated with high-dose chemotherapy with busulfan, melphalan, and thiotepa plus peripheral blood stem cell (PBSC) support followed by low dose immunotherapy with interleukin-2 (IL-2) and sargramostim (GM-CSF) for inflammatory stage IIIB and responsive stage IV breast cancer. - Determine the toxic effects of this therapy in these patients. OUTLINE: Peripheral blood stem cells (PBSC) are collected from the patient following stimulation with cyclophosphamide/paclitaxel/filgrastim (G-CSF) according to FHCRC 506 protocol or an approved FHCRC cytokine mobilization study. Patients must receive 1 course of cyclophosphamide and paclitaxel if cytokines alone are used to mobilize cells (FHCRC-506.03 protocol). G-CSF alone will be used to collect syngeneic PBSC (FHCRC-753). Patients receive oral busulfan every 6 hours on days -8, -7, and -6. Melphalan IV is given on days -5 and -4 beginning at least 12 hours after busulfan. Thiotepa IV is given on days -3 and -2 followed by PBSC infusion on day 0 beginning 36-48 hours after the last dose of thiotepa. All patients receive oral tamoxifen daily after transplant for 5 years or until relapse. Eligible patients receive interleukin-2 (IL-2) subcutaneously (SQ) daily plus sargramostim (GM-CSF) SQ on Monday, Wednesday, and Friday for 12 weeks beginning 30-100 days after transplantation. Patients with negative estrogen and progesterone status may discontinue tamoxifen therapy following IL-2/GM-CSF treatment. Patients receive radiotherapy after IL-2/GM-CSF treatment if no prior radiotherapy was given before transplantation. Patients are followed every 3 months for 2 years, then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 70 patients will be accrued for this study over 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Stage IIIB inflammatory breast cancer - Received 4-7 courses of doxorubicin or taxane based regimen - Responsive stage IV breast cancer metastatic to soft tissue and/or bone - Partial or complete response after initial chemotherapy for metastatic disease - Received 4-7 courses of doxorubicin or taxane based regimen OR - Locally recurrent disease rendered disease free after surgery or radiotherapy - Bone disease responsive if demonstrated sclerosis of prior lesions with no new lesions - Received 1 course of cyclophosphamide 4 g/m^2 and paclitaxel 250 mg/m^2 on protocol FHCRC-506.03 - Stem cell collection after mobilization with cyclophosphamide/paclitaxel or after an FHCRC approved cytokine protocol - Syngeneic stem cells collected by using filgrastim (G-CSF) according to protocol FHCRC-753 - Adequate number of peripheral blood stem cells stored (at least 2,500,000 CD34+ cells) - No CNS lesion (brain or carcinoid meningitis) - Hormone receptor status: - Any status PATIENT CHARACTERISTICS: Age: - 18 to 65 Menopausal status: - Not specified Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2 mg/dL - SGOT or SGPT no greater than 2.5 times normal Renal: - Creatinine no greater than 2 mg/dL OR - Creatinine clearance at least 50 mg/min Cardiovascular: - LVEF greater than 50% - LVEF must be performed for symptoms of congestive heart failure, abnormal cardiac exam, or history of doxorubicin total dose greater than 400 mg/m^2 Pulmonary: - No clinically significant pulmonary disease (diffusion capacity corrected less than 60% of predicted) Other: - Not pregnant - HIV negative - No history of seizures - No hypersensitivity to E. coli preparations - No active autoimmune disease - No significant active infection precluding transplantation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior transplantation Chemotherapy: - See Disease Characteristics - No more than 1 prior chemotherapy regimen for stage IV disease Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonaHolmberg, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000066035; FHCRC-1229.00,PSOC-1605,NCI-G98-1399
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003199
Other Stage 3b Breast Cancer Studies:
1. Herbal Therapy in Treating Women With Metastatic Breast Cancer
2. Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
4. Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
5. Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation
Related Studies:
Other stage 3B breast cancer Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
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