Interleukin-2 in Treating Patients With Mycosis Fungoides
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: aldesleukin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV] |
| Estimated Enrollment: | 30 |
| Study Start Date: | February 1995 |
| Study Completion Date: | July 2003 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Study Chair: | John A. Thompson, MD | Seattle Cancer Care Alliance |
More Information
No publications provided
| Responsible Party: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00002687 History of Changes |
| Other Study ID Numbers: | CDR0000064412, UW-24218-A/E, NCI-V95-0758 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Washington:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Mycoses Mycosis Fungoides Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin Aldesleukin Interleukin-2 |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013