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Home > "S" Clinical Trials Conditions > Stem Cell Transplantation for Metastatic Solid Tumors  Stem Cell Transplantation for Metastatic Solid Tumors
Stem Cell Transplantation for Metastatic Solid Tumors
For Condition: Cholangiocarcinoma,Colon/Rectal Ca,Bladder Ca,Breast Ca,Basal Cell Ca,Adrenal Ca,Esophageal/Gastric Ca,Hepatocellular Ca,Ovarian Ca,Prostate Ca,Small Cell Lung Ca,Non Small Cell Lung Ca,Adenocarcinoma, Unk origin,Pancreatic Ca,Bony/Soft Tissue Sarcoma
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: The goal of this research study is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation. Patients with a variety of different types of cancerous tumors that have spread (metastasized) and whose conditions have not improved with stand therapy, will be eligible to participate. Those patients selected to participate in the study will undergo a procedure known as a "mini-transplant". The mini-transplant is a transplantation of stem-cells collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow transplants, the mini-transplant does not require intense chemotherapy or radiation therapy. Because of this, patients experience fewer and less severe side effects. This study is open to patients diagnosed with a variety of metastatic solid tumors including esophageal, gastric (stomach), colon, rectal, liver tumors (hepatoma), cancer of the biliary system (cholangiocarcinoma), cancer of the pancreas, lung, breast, prostate, bone (sarcoma), adrenal basal cell, bladder, and adenocarcinomas of unk primary origin.
Details: The main objective of this study is to identify other metastatic neoplasms, which may be susceptible to the GVT effect. We will treat patients with progressive metastatic solid tumors refractory to standard therapy with a non-myeloablative allogeneic PBSC transplant from a family donor. A GVT effect from immunocompetent donor immune cells could extend life expectancy and possibly cure such patients. Eligible patients will be treated with an allogeneic peripheral blood stem cell transplant from an HLA identical or single HLA antigen-mismatched family donor, using an intensive immunosuppressive regimen without myeloablation ("mini-transplant") in an attempt to decrease the transplant related toxicities while preserving the anti-malignancy and/or anti-host marrow effect of the graft. The low intensity non-myeloablative conditioning regimen should provide adequate immunosuppression to allow stem cell and lymphocyte engraftment. A T-cell replete, donor-derived, granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood stem cells (PBSC) will be used to establish hematopoietic and lymphoid reconstitution. We will infuse lymphocytes in patients with <100% donor T-cell chimerism or with evidence of tumor progression in an attempt to prevent graft rejection and enhance a graft-versus-malignancy effect, respectively. This trial is open to several different types of metastatic, treatment-refractory, solid neoplasms (adrenal, basal cell, breast, transitional cell carcinoma of the bladder or uroepithelium, cholangiocarcinoma, small intestine/colon/rectal adenocarcinoma, esophageal/gastric, hepatocellular, ovarian, pancreatic, prostate, bony/soft tissue sarcomas, small cell lung cancer, non small cell lung cancer, and adenocarcinomas of unknown primary origin) other than malignant melanoma and RCC. The trial design permits up to 10 patients with a specific tumor type to be enrolled to screen for anti-tumor effects. A single complete response in a specific tumor type is an indication to exclude further patients with that diagnosis from the study. Subsequently, a new protocol which focuses on further defining a GVT effect in that disease category will be instituted.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: PATIENTS: Patients with metastatic solid tumors (adrenal, basal cell, breast, transitional cell carcinoma of the bladder or uroepitheleum, cholangiocarcinoma, small intestine/colon/rectal, adenocarcinoma, esophageal/gastric, hepatocellular, ovarian, pancreatic, prostate, bony/soft tissue sarcomas, small cell lung cancer, non small cell lung cancer, and adenocarcinomas of unknown primary origin) which are histologically confirmed, progressive and incurable. 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 5x 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.
Total Enrollment: 150
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 990064; 99-H-0064
Study Start Date: March 11, 1999
Record last reviewed: March 11, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001880
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Stem Cell Transplantation for Metastatic Solid Tumors
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