Exploratory Study of Non-Myeloablative Allogeneic Stem Cell Transplantation and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy

Study start date: March 12, 1999

INCLUSION CRITERIA: PATIENTS: Patients with metastatic solid tumors ( breast, cholangiocarcinoma, small intestine/colon/rectal, adenocarcinoma, esophageal/gastric, hepatocellular, pancreatic, prostate, bony/soft tissue sarcomas, which are histologically confirmed, progressive and incurable. Due to low accrual, effective 12/19/2006, patients with adrenal, basal cell, transitional cell carcinoma of the bladder or uroepithelium, ovarian, small cell lung cancer, non small cell lung cancer, and adenocarcinomas of unknown primary origin are no longer eligible for the trial. Age greater than or equal to 10 to less than or equal to 80. No known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Metastatic disease, which is bi-dimensionally evaluable radiographically. No prior treatment for neoplasm within 30 days. Ability to comprehend the investigational nature of the study and provide informed consent. Availability of HLA identical or single HLA-locus mismatched family donor. Willingness and availability to return to the NIH for scheduled follow-ups. DONOR: HLA identical or single HLA-locus mismatched family donor Age greater than or equal to 10 up to 80 years old. Ability to comprehend the investigational nature of the study and provide informed consent. EXCLUSION CRITERIA: PATIENT: Pregnant or lactating. Age less than 10 or greater than 80 years. ECOG performance status of 3 or more. Psychiatric disorder or mental deficiency severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Major anticipated illness or organ failure incompatible with survival from PBSC transplant. DLCO: less than 40% predicted. Left ventricular ejection fraction: less than 30%. Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hr urine collection. Serum bilirubin greater than 4 mg/dl Transaminases greater than 5 times the upper limit of normal. Oral intake less than 1,200 calories/day. Recent weight loss of greater than or equal to 10% of actual body weight. Life expectancy less than 3 months Therapy for malignancy within 4 weeks of beginning protocol. CNS metastatic disease associated with intracranial bleeding, uncontrolled seizure disorder or significant intracranial mass effect. Other malignant diseases liable to relapse or progress within 5 years. Uncontrolled infection. DONOR: Pregnant or lactating. Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia). Age less than 10 or greater than 80 years. HIV positive. Donors who are positive for HBV, HCV or HTLV-I may be used at the discretion of the investigator following counseling and approval from the recipient.