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

NCT00052377 | Terminated Phase 1

• 4 other identifiers: NCI-2012-0250410401R01CA089442CDR0000258239
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (4)

• Clinical response rate defined as the percentage of patients who achieve complete or partial response (Phase I)

  Up to week 13

• 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

• 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

• Toxicities graded using National Cancer Institute (NCI) Common Toxicity Criteria Version 2.0 (Phase I)

  Up to 6 months

Secondary Outcomes (6)

• Dose-limiting toxicity (DLT) is defined as any grade 3 or higher hematologic or non-hematologic toxicity (Phase II)

  Up to week 25

• 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

• 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

• Interferon gamma production

  Up to week 25

• Infiltration of skin lesions by CD8+ cells

  Up to week 25

Study Arms (1)

Treatment (aldesleukin, recombinant interleukin-12)

EXPERIMENTAL

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.

Biological: aldesleukin; Biological: recombinant interleukin-12; Other: laboratory biomarker analysis

Interventions

aldesleukin BIOLOGICAL

Given SC

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

Treatment (aldesleukin, recombinant interleukin-12)

recombinant interleukin-12 BIOLOGICAL

Given SC

Also known as: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472

Treatment (aldesleukin, recombinant interleukin-12)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (aldesleukin, recombinant interleukin-12)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

aldesleukin; Interleukin-2; Interleukin-12 Subunit p35; Interleukin-12

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Alain Rook

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: June 1, 2005
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)