Completed

Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]

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What is being tested

aldesleukin

Biological
Who is being recruted

Hemic and Lymphatic Diseases+10

+ Immune System Diseases

+ Immunoproliferative Disorders

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 1995
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: December 4, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1995

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides. Determine the response rate of patients treated with this regimen. Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients. OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses. 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 3 of 6 patients experience dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the MTD. Patients are followed at least 3 times during year 1 and then annually thereafter. PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.

NCT00002687
Principal SponsorUniversity of Washington
Last updated: December 4, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, T-CellLymphomaMycosis FungoidesSezary SyndromeLymphoma, T-Cell, Cutaneous

Criteria

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)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Washington Medical Center

Seattle, United StatesOpen University of Washington Medical Center in Google Maps
CompletedOne Study Center