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| Descriptive Information Fields | |||||
| Brief Title † | Peripheral Stem Cell Transplant and White Blood Cell Transfusions in Treating Patients With Refractory Metastatic Solid Tumors | ||||
| Official Title † | Exploratory Study of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy | ||||
| Brief Summary | RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before the transplant and cyclosporine after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well cyclophosphamide, fludarabine, antithymocyte globulin, and peripheral stem cell transplant followed by cyclosporin and donor white blood cell transfusions work in treating patients with refractory metastatic solid tumors. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to risk of graft rejection, which determines the preparative regimen received. High-risk patients include heavily transfused patients or patients who have received donor-directed blood products and single HLA-locus mismatched patients. Preparative regimen: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1. Patients at high risk also receive antithymocyte globulin IV on days -5 to -2. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients receive cyclosporine either by continuous infusion IV or orally twice a day on days -4 to 100 as graft-versus-host disease (GVHD) prophylaxis. Patients with less than 100% donor T-cell chimerism or with evidence of tumor progression receive donor lymphocytes after day 100, every 4 weeks, until 100% donor T-cell chimerism, disease regression, and/or GVHD occurs. Patients are followed at 4, 6, 8, 10, and 12 months, every 3 months for 2 years, and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 150 patients (10 for each cancer) will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | Graft vs tumor effect as measured by CAT scans at days 30, 60, and 100 following transplant [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Disease-free survival as measured by CAT scans at 6 months and 1 year [ Designated as safety issue: No ] | ||||
| Condition † | Breast Cancer Carcinoma of Unknown Primary Colorectal Cancer Esophageal Cancer Gallbladder Cancer Gastric Cancer Liver Cancer Lung Cancer Pancreatic Cancer Prostate Cancer Sarcoma |
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| Intervention † | Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation |
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| MEDLINE PMIDs | 15983554, 16173966, 14551148, 14746531, 15485320, 11895199, 12203140, 15033656, 11799523, 11799531, 12466756, 11360122, 11091178, 10894356 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 150 | ||||
| Start Date † | March 1999 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 10 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00003839 | ||||
| Organization ID | CDR0000066997 | ||||
| Secondary IDs †† | NHLBI-99-H-0064 | ||||
| Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||
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