Interleukin-2 in Treating Patients With Mycosis Fungoides

NCT00002687 | Completed Phase 1

• 3 other identifiers: CDR0000064412UW-24218-A/ENCI-V95-0758
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides.

Conditions

Lymphoma

Keywords

stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome

Interventions

aldesleukin BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Clinically and histologically proven diagnosis of 1 of the following: * Mycosis fungoides (MF) meeting 1 of the following conditions: * Stage IIB disease that has failed psoralen ultraviolet A (PUVA) light therapy and topical chemotherapy (mechlorethamine and/or carmustine) * Stage III disease with generalized erythroderma * Stage IV disease with biopsy proven nodal or visceral involvement * Sezary syndrome * Stage III MF with a minimum of 20% Sezary cells (based on total WBC) * No clinically significant ascites or pleural effusion * Clinically significant pleural effusion defined as shortness of breath with oxygen saturation less than 90% PATIENT CHARACTERISTICS: Age: * 18 to 80 Performance status: * Karnofsky 70-100% Life expectancy: * At least 16 weeks Hematopoietic: * See Disease Characteristics * WBC at least 3,500/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 11.5 g/dL Hepatic: * Bilirubin less than 2.5 times normal * SGOT less than 2.5 times normal Renal: * Creatinine no greater than 2.0 mg/dL * No nephrotic syndrome Cardiovascular: * No history of myocardial infarction or congestive heart failure * No symptomatic coronary artery disease * No clinically manifest hypotension * No severe hypertension * No arrhythmia on electrocardiogram * No edema * No contraindication to pressor agents Pulmonary: * See Disease Characteristics * No dyspnea at rest or severe exertional dyspnea Neurologic: * No significant CNS dysfunction, including any of the following: * Seizure disorder * Active cerebrovascular disease * Dementia or delirium Other: * No autoimmune disease, including psoriasis * No uncontrolled peptic ulcer disease * No uncontrolled infection * No history of adverse reaction to interleukin-2 * HIV and HTLV-I negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior systemic or topical chemotherapy (6 weeks since prior mitomycin or nitrosoureas) Endocrine therapy: * At least 1 week since prior corticosteroids * No concurrent corticosteroids Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * No prior organ allograft * At least 3 weeks since other prior major surgery Other: * At least 4 weeks since prior immunosuppressive therapy * At least 2 weeks since prior phototherapy (ultraviolet B \[UVB\] or PUVA light therapy) * No concurrent phototherapy (UVB or PUVA light therapy)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

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

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

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

Study Officials

• John A. Thompson, MD

  Seattle Cancer Care Alliance

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1995
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

US (1)