Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides

Stopped early · Phase 1/Phase 2

Conditions studied: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome

In brief

Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in treating patients who have mycosis fungoides. Biological therapies, such as interleukin-12 and interleukin-2, use different ways to stimulate the immune system and stop cancer cells from growing. Combining more than one biological therapy may kill more tumor cells

Key facts

Study ID

NCT00052377

Run by

National Cancer Institute (NCI)

People needed

46

Starts

2002-09-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed mycosis fungoides
• Stage Ib-IV
• At least 5% of total blood mononuclear cells must be CD8-positive lymphocytes
• No CNS disease
• Performance status - Karnofsky 70-100%
• At least 6 months
• WBC ≥ 3,000/mm\^3 but ≤ 40,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 10 g/dL (transfusion or epoetin alfa allowed)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2 times ULN
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance ≥ 60 mL/min
• EKG normal
• No known cardiac and peripheral vascular disease
• No cardiac arrhythmias requiring medical treatment
• Chest x-ray normal
• No history of or clinically significant autoimmune disease (e.g., rheumatoid arthritis), autoimmune hemolytic anemia, or positive Coombs' test
• No HTLV-I or HTLV-II-associated disease
• HIV negative
• Antinuclear antibody negative
• Rheumatoid factor negative
• No serious concurrent infection requiring IV antibiotics
• No clinically significant gastrointestinal bleeding

Where it is running

• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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