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Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast Clinical research trials and Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast. Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast clinical trial. Human subjects often get the best healthcare possible for their Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast  Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast
Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): UCSD Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Donor peripheral stem cell transplantation may be an effective treatment for breast cancer that has not responded to previous chemotherapy or has spread to the bone marrow. Combining antithymocyte globulin with melphalan and fludarabine before transplantation may reduce the chance of developing graft-versus-host disease. PURPOSE: Phase IIpilot study of allogeneic peripheral stem cell transplantation after antithymocyte globulin, high-dose melphalan, and fludarabine in treating women who have metastaticadenocarcinoma of the breast.
Details: OBJECTIVES: Primary - Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin, high-dose melphalan, and fludarabine in women with chemotherapy-refractory or poor-prognosis metastatic adenocarcinoma of the breast. - Determine the ability of this preparative regimen to facilitate long-term engraftment of allogeneic stem cells and lymphocytes in these patients. - Determine the response in measurable/evaluable disease and its temporal relationship to the preparative chemotherapy used and to the onset of clinical graft-versus-host disease (GVHD) in patients treated with this regimen. Secondary - Determine the progression-free and overall survival of patients treated with this regimen. - Determine the tumor response and its temporal relationship to administration of high-dose chemotherapy and to the onset of GVHD in patients treated with this regimen. - Determine the frequency and durability of the induction of full donor chimerism of lymphocytes in patients treated with this regimen. OUTLINE: This is a nonrandomized, pilot study. - Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4, anti-thymocyte globulin IV over 4 hours on days -7 to -4, and high-dose melphalan IV over 30 minutes on days -3 and -2. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV (and then orally when tolerated) every 12 hours beginning on day -4 and tapered after day 42 (if no GVHD occurs) or after day 90 (if grade I acute GVHD occurs). Patients also receive methotrexate IV on days 1, 3, and 6. - Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo allogeneic PBSCT on day 0. Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on day 0 and continuing until blood counts recover. - Donor lymphocyte infusion (DLI): Patients who show disease progression or fail to achieve full donor type T-cell chimerism (at least 90% donor derived T-cells) by the 90-day assessment posttransplantation, and have no evidence of active GVHD may receive DLI. Patients who have unresponsive disease with no active GVHD receive subsequent DLIs every 6-8 weeks. Patients are followed at 1, 3, 6, 12, 18, 24, 30, and 36 months. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Metastatic disease - Meets 1 of the following criteria: - Chemotherapy-unresponsive disease defined as 1 of the following: - Less than a partial response to 2 consecutive chemotherapy regimens that included an anthracycline and a taxane in combination or succession - Progression of disease during or within 3 months of completion of a taxane, anthracycline, or platinol-based regimen - Histologically confirmed tumor involvement on bone marrow biopsy - Measurable or evaluable disease* defined as the following: - Bidimensionally reproducible measurable mass by physical examination, ultrasonography, radiography, CT scan, or MRI - Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not fit the criteria for measurability (e.g., ill-defined post-surgical masses or masses assessable in 1 dimension only) - Elevation of biological markers (e.g., CA 27.29) is considered evaluable disease NOTE: *Bone lesions or pleural or peritoneal effusion alone are not considered measurable or evaluable disease - Appropriate candidate for allogeneic stem cell transplantation - No active CNS metastases - Available HLA-identical sibling donor - 6/6 antigen match - Donor CD34 cells at least 2 times 10^6/kg recipient weight - Hormone receptor status: - Estrogen receptor negative or positive - Estrogen receptor positive tumors must demonstrate progression on at least 1 hormonal manipulation PATIENT CHARACTERISTICS: Age - 18 to 60 Sex - Female Menopausal status - Not specified Performance status - Karnofsky 70-100% OR - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC at least 1,500/mm^3 - Platelet count at least 30,000/mm^3 Hepatic - Bilirubin less than 3 times normal* - AST and ALT less than 3 times normal* NOTE: *Unless abnormality due to malignancy Renal - Creatinine no greater than 1.6 mg/dL Cardiovascular - LVEF greater than 40% by echocardiography or MUGA - No myocardial infarction within the past 6 months Pulmonary - DLCO greater than 40% of predicted Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No serious localized or systemic infection - No hypersensitivity to E. coli-derived products - No history of non-breast malignant disease within the past 5 years except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix - No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other immunosuppressive medication - No psychological condition or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - No concurrent glucocorticoids Radiotherapy - No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy Surgery - Not specified Other - No concurrent immunosuppressive medication
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AsadBashey, Principal Investigator, UCSD Cancer Center
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0690
United States
Recruiting Asad Bashey 858-657-6790
Additional Information:
Study ID Numbers: CDR0000343758; UCSD-020815
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074269
Other Stage 4 Breast Cancer Studies:
1. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
2. Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
3. Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
4. 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
5. Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
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Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast
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