Lymphoma Clinical Trial
Official title:
Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]
Verified date | November 2012 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2003 |
Est. primary completion date | July 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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) |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
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