Expired Study
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Seattle, Washington 98195


Purpose:

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.


Study summary:

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.


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 is Available At:


Original ID:

CDR0000064412


NCT ID:

NCT00002687


Secondary ID:

UW-24218-A/E


Study Acronym:


Brief Title:

Interleukin-2 in Treating Patients With Mycosis Fungoides


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:John A. Thompson, MD
Study Chair
Seattle Cancer Care Alliance

Study Dates

Start Date:February 1995
Completion Date:July 2003
Completion Type:Actual
Primary Completion Date:July 2003
Primary Completion Type:Actual
Verification Date:November 2012
Last Changed Date:November 30, 2012
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:aldesleukin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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