INCLUSION CRITERIA:
All patients must have a histologically confirmed diagnosis of malignancy by the NIH Laboratory of Pathology.
Patients with prostate cancer must:
-have been treated on NCI protocol 00-C-0137 or 00-C-0154
-have progressive disease as evidenced by either two consecutively rising PSA levels or new bone scan lesion or progression of soft-tissue per RECIST criteria.
The first rising PSA must be a minimum of one week from a reference value. It is recognized that PSA fluctuations are such that the confirmatory PSA value might be less then the previous one. In these cases the patient would still be eligible provided the next PSA was greater than the first rising PSA value. Patients must have a PSA greater than or equal to 5.0.
Patients must have progression androgen-independent prostate cancer. Patients on flutamide must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide must have progression at least 6 weeks after withdrawal.
-Patients may received intervening therapy
Patients with non-Hodgkin's or Hodgkin's lymphoma must
-patients must have been treated with NCI idiotype vaccine protocols 00-C-0133, 01-C-0169, 00-C-0050.
-patients must have progressive disease as defined by the non-Hodgkin's lymphoma response criteria. The same response criteria will be used for patients with Hodgkin's lymphoma.
-patients may have received intervening therapy
-any patient with progressive follicular lymphoma may be entered in group 2.
-Any patient with recurrent lymphoma that is refractory to standard therapy is eligible for treatment in group 3. Patients cannot have therapeutic options that are curative. Patients with aggressive lymphomas must have undergone autologous stem cell transplant or refused those approaches. Patients with mycosis fungoides must have at least stage 2 disease that is unresponsive to two previous therapies.
Patients with colon cancer must
-have been treated on NCI protocol 99-C-0023
-have progressive disease as defined by RECIST criteria
-patients may have received intervening therapy.
The patient must have a WBC greater than or equal to 2500/mm(3), granulocyte count greater than or equal to 1000/mm(3), platelet count greater than or equal to 50,000/mm(3), hemoglobin greater that or equal to 10 g/dL, hematocrit greater than or equal to 30 percent.
Patients must have a creatinine less than or equal to 2.0 mg/dL.
Patients must have SGOT and SGPT value less than or equal to 3.0-fold greater than the upper limit of normal and bilirubin less than or equal to 3.0/dL, unless due to Gilberts disease.
Patients must have a negative rheumatoid factor if there is evidence of or a history of arthritis and an ANA less than or equal to 1:80 if there is a history of or there are clinical signs or symptoms suggestive of a connective tissue disease.
Omission of cytotoxic chemotherapy and steroids for four weeks prior to entry into the trial is required.
Patients must have a life expectancy of greater than 2 months.
Eligible patients must be greater than or equal to 18 years old. There is no upper age limit.
Patients must be able to understand and sign an Informed Consent form.
Patients must have received vaccine treatment within fourteen months of study entry.
Patients entered into this study must have no other standard treatment options with documented survival advantage or they must have refused such therapy. Patients with symptomatic or rapidly progressive malignancy requiring therapy will not be eligible.
Patients must have a Karnofsky Performance Status greater than 70 percent.
EXCLUSION CRITERIA:
Patients with any other active malignancy other than adequately treated squamous or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or superficial bladder carcinoma. Patients who are less than five years from the curative therapy of their malignancy will be considered to have active second malignancy.
Patients with a history of or active autoimmune disease for example uveitis, rheumatoid arthritis, lupus erythematosus. Patients with positive antibody titers for diseases screened for in the autoimmune panel will be excluded. (Patients with positive rheumatoid factor or ANA will not be excluded unless the titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease.)
Patients with active infection.
Pregnant and nursing patients are not eligible for the study because the effects of ipilimumab on the developing fetus and the nursing infant are unknown.
HIV or hepatitis B surface Antigen positive patients and patients positive for antibodies to hepatitis C are excluded from the study because the toxicity may be different in this population.
In group 1, patients who previously received ipilimumab therapy. Previous ipilimumab treatment (less than 5 treatments) will be permitted for patients treated in group 2.
Patients with symptomatic central nervous system metastases.
Patients who require concurrent systemic or topical steroid therapy. Steroid therapy must have been discontinued four weeks before study entry.
Patients with acute toxicity attributed to prior vaccine therapy are not eligible.
Patients receiving any immunosuppressant (e.g., infliximab, cyclosporin and its analog, 6-mercaptopurine, methotrexate, cyclophosphamide etc.)
Patients who are unwilling to use birth control to prevent conception during treatment and for four months after completion of therapy. Both men and women are required to prevent conception for this period.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009