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Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors Clinical research trials and Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors. Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors  Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors
Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors
For Condition: Cancer
Status: Recruiting
Sponsor(s): Roger Williams Medical 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 plus biological therapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation plus biological therapy in treating patients who have stage IIIB or stage IV breast cancer or other solid tumors.
Details: OBJECTIVES: - Determine the toxic effects of autologous peripheral blood stem cell transplantation followed by immunotherapy with activated T cells, low-dose interleukin-2, and sargramostim (GM-CSF) in patients with stage IIIB or IV breast cancer or other solid tumors. - Determine the efficacy of this regimen in these patients. - Determine the effects of this regimen on immune reconstitution in these patients. OUTLINE: Patients are stratified according to disease (stage IIIB breast vs stage IV breast vs solid tumors). Patients with breast cancer are also stratified according to tumor classification (chemosensitive vs chemoresistant). Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 5 days followed by peripheral blood mononuclear cell (PBMC) collection. The PBMC are treated ex vivo with monoclonal antibody OKT3 to form activated T cells (ATC). The ATC are expanded for 12-14 days in interleukin-2 (IL-2). Patients are then reprimed with cyclophosphamide, paclitaxel, and G-CSF followed by peripheral blood stem cell (PBSC) collection. Patients then receive high-dose chemotherapy. Patients with chemosensitive disease receive busulfan IV on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Patients with chemoresistant disease receive ifosfamide IV, carboplatin IV, and etoposide IV on days -8 to -3. Patients undergo autologous PBSC transplantation on day 0. Patients then receive ATC IV over 15-20 minutes twice weekly on days 14-70. Patients also receive low-dose IL-2 SC daily and sargramostim (GM-CSF) SC twice weekly on days 14-77. Patients are followed at 3 and 6 months post-transplantation and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients (10-15 with solid tumors) will be accrued for this study within 3-4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IIIB or IV carcinoma of the breast - Bilateral disease allowed - Concurrent intraductal or lobular carcinoma in situ allowed - Measurable or evaluable recurrent metastatic disease - Nonmeasurable disease allowed if tumor or metastatic disease has been previously removed or successfully treated OR - Diagnosis of solid tumor including but not limited to: - Ovarian carcinoma - Ewing's sarcoma - Small cell lung cancer - Germ cell tumor - Relapsed solid tumor after prior PBSC transplantation allowed - No clinical evidence of brain metastases - No significant CNS disease - Hormone receptor status: - Estrogen or progesterone status known PATIENT CHARACTERISTICS: Age: - 13 and over Sex: - Female (breast cancer) - Male or Female (solid tumor) Menopausal status: - Not specified Performance status: - Karnofsky 70-100% - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Leukocyte count at least 2,000/mm^3 - Lymphocyte count at least 1,000/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 50,000/mm^3 - Hemoglobin greater than 8 g/dL Hepatic: - Bilirubin less than 1.5 times normal - SGOT less than 1.5 times normal - PT/PTT no greater than 1.5 times control Renal: - Creatinine less than 1.8 mg/dL - Creatinine clearance at least 60 mL/min - BUN less than 1.5 times normal - Calcium no greater than 12 mg/dL Cardiovascular: - No uncontrolled or significant cardiovascular disease - No myocardial infarction within the past year - No significant congestive heart failure - Ejection fraction at least 45% at rest by MUGA Pulmonary: - PFT-FEV_1 at least 60% predicted - DLCO2 at least 60% predicted - FVC at least 60% predicted Other: - No other malignancy except curatively treated squamous cell carcinoma in situ of the cervix or basal cell skin cancer - No uncontrolled or untreated psychiatric or seizure disorders - No uncontrolled bacterial, viral, or fungal infection - No other serious medical or psychiatric illness that would preclude study participation - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - Prior bone marrow transplantation allowed Chemotherapy: - Not specified Endocrine therapy: - At least 7 days since prior corticosteroids except therapeutic doses for respiratory ailments or adrenal insufficiency - Concurrent steroids for adrenal failure, septic shock, or pulmonary toxicity allowed - Concurrent hormones for non-disease related conditions (e.g., insulin for diabetes) allowed - No concurrent hormonal therapy for breast cancer Radiotherapy: - Not specified Surgery: - See Disease Characteristics - No prior solid organ allograft
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrenceLum, Study Chair, Roger Williams Medical Center
Roger Williams Medical Center *Recruiting*
Providence, Rhode Island, 02908-4735
United States
Recruiting Lawrence Lum 401-456-2672
Additional Information:
Study ID Numbers: CDR0000068707; RWMC-034246
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020722
Other Cancer Studies:
1. Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
2. Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
3. Biomarkers of Benzene Exposure in Inner City Residents
4. UCN-01 and Irinotecan in Treating Patients With Metastatic or Unresectable Solid Tumors
5. Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Related Studies:
Other Cancer Clinical Trials
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Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors
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