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Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome


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.

Inclusion 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- No concurrent steroids

Radiotherapy:

- See Disease Characteristics

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent proven or investigational antineoplastic therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 96H7

NCT ID:

NCT00005788

Start Date:

April 1997

Completion Date:

January 2002

Related Keywords:

  • Lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • 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 I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Boston Medical CenterBoston, Massachusetts  02118