Expired Study
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Bethesda, Maryland 20892


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.

Study summary:

OBJECTIVES: Primary: - Identify an anti-tumor effect of allogeneic peripheral blood stem cell transplantation by induction of a graft-versus-tumor effect in patients with a diversity of metastatic solid tumors refractory to standard therapy. Secondary: - Determine engraftment in these patients. - Determine the effects of donor lymphocyte infusion and cyclosporine withdrawal on tumor regression in these patients. 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.


DISEASE CHARACTERISTICS: - Histologically proven progressive and incurable metastatic solid tumors - Hepatocellular carcinoma - Pancreatic carcinoma - Cholangiocarcinoma - Esophageal carcinoma - Gastric carcinoma - Colon and rectal carcinoma - Breast carcinoma - Hormone-refractory prostate carcinoma - Soft tissue sarcomas - Bony sarcomas - Refractory to standard therapy or no known curative therapy exists - Bidimensionally evaluable metastatic disease by radiography - HLA-identical or single HLA-locus mismatched family donor available - No CNS metastases associated with intracranial bleeding, uncontrolled seizure disorder, or significant intracranial mass effect - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 10 to 80 Sex: - Not specified Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 4 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/dL Cardiovascular: - LVEF at least 30% Pulmonary: - DLCO at least 40% predicted Other: - Not pregnant or nursing - No psychiatric disorder or severe mental deficiency - No other major illness or organ failure - Oral intake at least 1,200 calories/day - No recent weight loss of 10% or more - No other malignant diseases liable to relapse or progress within 5 years - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 30 days since prior cancer therapy



Primary Contact:

Study Chair
Richard W. Childs, MD
National Heart, Lung, and Blood Institute (NHLBI)

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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