Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome

Northwestern University

Status and phase

Terminated

Phase 2

Conditions

Lymphoma

Treatments

Biological: aldesleukin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00005788

NCI-G00-1735

NU 96H7

NU-96H7

Details and patient eligibility

About

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome.

Full description

OBJECTIVES:

Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 (IL-2).
Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or stable disease continue treatment for 2 courses past best response. Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically proven mycosis fungoides or Sezary syndrome
- Any stage
Measurable disease with 1 or more indicator lesions
- Evaluable disease for erythrodermic patients only
At least 2 weeks since prior therapy, if documented progressive disease (PD)
At least 4 weeks since prior therapy, if best response achieved without clear evidence of PD

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Absolute granulocyte count at least 1,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 2.2 mg/dL

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No New York Heart Association class III or IV heart disease
No cardiac pacemaker
No clinically significant peripheral venous insufficiency

Other:

No other malignancy within the past 5 years except:
- Treated squamous cell or basal cell skin cancer
- Treated carcinoma in situ of the cervix
- Surgically treated other cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
HIV negative
No poorly controlled diabetes mellitus