Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II Open-Label Study Of Recombinant Human Interleukin-12 (NSC 672423) In Mycosis Fungoides (MF) Patients With Cross-Over To Phase I Evaluation Of Escalating Doses Of Interleukin-2 (NSC 373364) Administered With Interleukin-12
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
Status | Terminated |
Enrollment | 46 |
Est. completion date | |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - No uncontrolled peptic ulcer disease - No history of inflammatory bowel disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of peripheral neuropathy - No other major illness that would substantially increase the patient's risk - Prior interferon allowed - Prior denileukin diftitox allowed - No prior interleukin (IL)-2 or IL-12 - No prior anti-T-cell monoclonal antibody therapy - No other concurrent biologic therapy - Prior topical imidazole mustard or carmustine allowed - Prior bexarotene allowed - Prior oral methotrexate allowed - At least 3 weeks since prior topical chemotherapy - At least 8 weeks since prior treatment with any single chemotherapeutic agent (12 weeks for multiple chemotherapeutic agents) - Treatment must not have included steroids - No prior systemic chemotherapy - No prior fludarabine, pentostatin, or cladribine - No concurrent systemic chemotherapy - At least 3 weeks since prior topical or systemic steroids more potent than 1% hydrocortisone - No concurrent systemic corticosteroids - No concurrent low-potency steroid creams - No concurrent radiotherapy - Not specified - At least 3 weeks since prior psoralen-ultraviolet-light (PUVA) or ultraviolet B (UVB) - At least 3 weeks since prior retinoids - At least 3 weeks since prior investigational drugs - Prior photopheresis allowed - No other concurrent investigational therapy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response rate defined as the percentage of patients who achieve complete or partial response (Phase I) | Up to week 13 | No | |
Primary | Refractory disease defined as a patient who initially shows clinical improvement in the early weeks of treatment and then exhibits a response plateau for >= 30 days or exhibits progression of their disease (Phase I) | Logistic regression may be employed to explore the relationships between clinical response or refractory disease and baseline patient features. | Up to week 13 | No |
Primary | Improved clinical response defined as a patient who had refractory or persistent disease and who subsequently had a >= 25% clinical improvement for >= 30 days during aldesleukin and recombinant interleukin-12 therapy (Phase II) | Up to week 25 | No | |
Primary | Toxicities graded using National Cancer Institute (NCI) Common Toxicity Criteria Version 2.0 (Phase I) | Up to 6 months | Yes | |
Secondary | Dose-limiting toxicity (DLT) is defined as any grade 3 or higher hematologic or non-hematologic toxicity (Phase II) | Up to week 25 | Yes | |
Secondary | Maximum tolerated dose (MTD), defined as the dose level at which at least 2 of 3 patients or at least 2 of 6 patients experience DLT, graded according to the NCI CTC v2.0 (Phase II) | Up to week 25 | Yes | |
Secondary | Recommended dose (RD), defined as the dose level at which 0/6 or 1/6 patients experience DLT and at least 2 patients treated at a higher dose level experience DLT (Phase II) | Up to week 25 | Yes | |
Secondary | Interferon gamma production | Compared between the two groups by two independent samples t-test or nonparametric Mann-Whitney test, as appropriate. | Up to week 25 | No |
Secondary | Infiltration of skin lesions by CD8+ cells | Up to week 25 | No | |
Secondary | Induction of apoptosis in infiltrating tumor cells in the skin | Up to week 26 | No |
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