Full Text View
Tabular View
No Study Results Posted
Related Studies
Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
This study has been completed.
First Received: January 24, 2003   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Pennsylvania
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052377
  Purpose

RATIONALE: 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.

PURPOSE: Phase I/II trial to study the effectiveness of combining interleukin-12 with interleukin-2 in treating patients who have mycosis fungoides.


Condition Intervention Phase
Lymphoma
Biological: aldesleukin
Biological: recombinant interleukin-12
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2002
Detailed Description:

OBJECTIVES:

  • Determine the response rate (complete and partial) in patients with mycosis fungoides treated with interleukin-12 (IL-12).
  • Determine the frequency of refractory disease in patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.
  • Determine the feasibility and dose-limiting toxic effects (DLT) of interleukin-2 (IL-2) when administered with IL-12 in patients who have not shown disease progression after 12 weeks of IL-12 and in those who have shown disease progression after 12 weeks of IL-12.
  • Determine the maximum tolerated dose and recommended dose of IL-2 when administered with IL-12 in these patients.
  • Determine immune and cytokine response over time in patients treated with this regimen.
  • Determine the frequency of improved clinical response in patients treated with this regimen.
  • Determine the biologic correlates of response, including levels of interferon gamma production, natural killer cell activity, infiltration of skin lesions by CD8-positive cells, lymphocyte IL-12 receptor expression, signal transducers and activators of transcription protein levels and IL-12 signal transduction, and induction of apoptosis in tumor cells in the skin of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter, dose-escalation study of interleukin-2 (IL-2).

Patients receive interleukin-12 (IL-12) subcutaneously (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 maximum tolerated dose (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 recommended dose (RD) is the dose preceding the MTD. Additional patients are treated at the RD.

Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 28 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed mycosis fungoides

    • Stage Ib-IV
  • At least 5% of total blood mononuclear cells must be CD8-positive lymphocytes
  • No CNS disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 6 months

Hematopoietic

  • 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)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • EKG normal
  • No known cardiac and peripheral vascular disease
  • No cardiac arrhythmias requiring medical treatment

Pulmonary

  • Chest x-ray normal

Immunologic

  • 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

Gastrointestinal

  • No clinically significant gastrointestinal bleeding
  • No uncontrolled peptic ulcer disease
  • No history of inflammatory bowel disease

Other

  • 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 CONCURRENT THERAPY:

Biologic therapy

  • 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

Chemotherapy

  • 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

Endocrine therapy

  • 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

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052377

Locations
United States, California
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Massachusetts
Cancer Center at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Pennsylvania
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Chair: Alain H. Rook, MD University of Pennsylvania
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000258239, UPCC-10401, NCI-1831
Study First Received: January 24, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00052377     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma

Study placed in the following topic categories:
Interleukin-12
Immunologic Factors
Sezary Syndrome
Mycosis Fungoides
Lymphoma, Small Cleaved-cell, Diffuse
Mycoses
Anti-Retroviral Agents
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Analgesics
Lymphoma
Immunoproliferative Disorders
Anti-HIV Agents
Adjuvants, Immunologic
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Lymphatic Diseases
Aldesleukin
Interleukin-2
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Anti-Infective Agents
Interleukin-12
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Sezary Syndrome
Mycosis Fungoides
Mycoses
Anti-Retroviral Agents
Sensory System Agents
Lymphoma, T-Cell
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Analgesics
Lymphoma
Anti-HIV Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Growth Substances
Adjuvants, Immunologic
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Aldesleukin
Interleukin-2
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on July 02, 2009