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Investigator(s):
John E. Janik, M.D. Principal Investigator Phone: 301-402-2913 janikj@mail.nih.gov
Referral Contact(s):
Guinevere Chun, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-451-7868 Fax: 301-402-1001 gchun@mail.nih.gov	Suzanne Fioravanti, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-6544 Fax: 301-402-1001 fioravas@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed non-Hodgkin’s lymphoma or Hodgkin’s lymphoma
• Progressive disease
• No other standard therapy available or refused such therapy
• No symptomatic or rapidly progressive malignancy requiring therapy
• No symptomatic CNS metastases
• Recovered from all prior therapy
• No concurrent therapy allowed
• Karnofsky 80–100%
• WBC ≥ 2,500/mm³; granulocyte count ≥ 1,500/mm³; platelet count ≥ 50,000/mm³; hemoglobin ≥ 10 g/dL; hematocrit ≥ 30%
• Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert’s disease); SGOT and SGPT ≤ 3 x upper limit of normal (ULN); hepatitis B surface antigen negative; hepatitis C antibody negative
• Creatinine ≤ 2.0 mg/dL
• No prior or active autoimmune disease
• HIV negative
• Not pregnant of nursing; fertile patients must use effective contraception during and for 4 months after study participation
• No other medical conditions that would preclude study participation

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Treatment Plan:

This is a pilot, partial dose-escalation study.

Part I (closed to accruals for patients with prostate, colon, follicular, or mantle cell lymphoma since 2005)

Part II (patients with follicular lymphoma only)
• Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA-4) IV over 90 minutes on Day 1
• Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
• Cohorts of 3–6 patients receive escalating doses of MDX-CTLA-4 until the maximum tolerated dose (MTD) is determined; the MTD is defined as the dose preceding at which 2 of 6 patients experience dose-limiting toxicity

Part III (patients with non-Hodgkin’s or Hodgkin’s lymphoma)
• Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA-4) IV over 90 minutes on Day 1
• Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
• Patients are followed every other month

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/18/08
Updated: 10/15/08