search
Back to results

Interleukin-2 in Treating Patients With Mycosis Fungoides

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Washington Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 30, 2012
Sponsor
University of Washington
search

1. Study Identification

Unique Protocol Identification Number
NCT00002687
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]
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 1995 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Thompson, MD
Organizational Affiliation
Seattle Cancer Care Alliance
Official's Role
Study Chair
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Interleukin-2 in Treating Patients With Mycosis Fungoides

We'll reach out to this number within 24 hrs