Peripheral Stem Cell Transplantation and White Blood Cell Transfusions in Treating Patients With Refractory Metastatic Solid Tumors

This study is not yet open for patient recruitment.

Sponsored by

National Cancer Institute (NCI)

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte globulin and cyclosporine may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation and donated white blood cell transfusions in treating patients who have refractory metastatic solid tumors.

Study Type: Treatment

Official Title: Phase II Study of Nonmyeloblative Allogeneic Peripheral Blood Stem Cell and Donor Lymphocyte Infusions in Patients with Refractory Metastatic Solid Tumors

Further Study Details: OBJECTIVES: I. Determine the efficacy of allogeneic peripheral blood stem cell transplantation by induction of a graft versus tumor effect in patients with refractory metastatic solid tumors. II. Determine engraftment in these patients. III. Determine the effects of donor lymphocyte infusion and cyclosporine withdrawal on tumor regression in these patients.  PROTOCOL 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 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 graft versus host disease occurs. Patients are followed at 4, 6, 8, 10, and 12 months, then every 3 months for 2 years, then every 6 months for 2 years.  PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study, with a maximum of 10 patients accrued for each cancer.  

Eligibility

Ages Eligible for Study:  10 Years    -   80 Years Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven, progressive, and incurable metastatic solid tumors Hepatocellular carcinoma Pancreatic carcinoma Cholangiocarcinoma Esophageal carcinoma Gastric carcinoma Colon and rectal carcinoma Small cell lung carcinoma Nonsmall cell lung carcinoma Breast carcinoma Hormone refractory prostate carcinoma Salivary tumors Soft tissue sarcomas Bony sarcomas Adenocarcinoma of unknown primary Basal cell skin carcinoma Squamous cell skin carcinoma 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 --Prior/Concurrent Therapy-- At least 30 days since prior cancer therapy --Patient Characteristics-- Age: 10 to 80 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 at least 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 1200 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

Location and Contact Information

Richard W. Childs       301-496-5093    Study chairs or principal investigators

Richard W. Childs,  Study Chair

National Heart, Lung, and Blood Institute (NHLBI)   

More Information

Study ID Numbers  199/14185;   NHLBI-99-H-0064

NLM Identifier  NCT00003839

Last Updated  December 1, 1999

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