Stem Cell Transplantation for Metastatic Solid Tumors
Condition: Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis
Intervention: methotrexate; Cyclosporin
Intervention description: Cyclosporin beginning day -4 and intravenous Methotrexate on days +1, +3, and +6 will be given; Cyclosporin beginning day -4 and intravenous Methotrexate on days +1, +3, and +6 will be given
Intervention MeSH terms: Cyclosporine; Methotrexate; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 10 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Engraftment; Peripheral Blood Stem Cells; Non-Myeloablative Bone Marrow Transplantation; Metastatic Solid Tumors; Graft-Versus-Host Disease; Cancer; Tumor

Summary:

      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.
    

Eligibility criteria:

        -  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.