Clinical trial · Interventional
Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
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
NCT00052377CI-TRIAL-00008944terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
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
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mycosis Fungoides/Sezary Syndrome | — | UNRESOLVED | — |
| Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage II Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage III Mycosis Fungoides/Sezary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (aldesleukin, recombinant interleukin-12)
- description
- Patients receive IL-12 SC twice weekly for 24 weeks. Disease is assessed at 13 weeks. Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24. Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24. Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks. Cohorts of 3-6 patients receive escalating doses of IL-2 until the MTD is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The RD is the dose preceding the MTD. Additional patients are treated at the RD.
- interventionNames
- Biological: aldesleukin
- Biological: recombinant interleukin-12
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Clinical response rate defined as the percentage of patients who achieve complete or partial response (Phase I)
- timeFrame
- Up to week 13
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.