Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Topical Treatment With Photodynamic Therapy, Chemotherapy, or Radiation Therapy Compared With Topical Treatment Plus Interferon alfa in Treating Patients With Cutaneous T-cell Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 and over NCI ECOG-1495 E1495

Objectives

I.  Determine if the addition of interferon alfa-2b to standard topical 
treatments for CTCL affects time to progression, overall response rate, and 
time to response.

II.  Determine the survival duration and toxic effects in patients with stage 
IB, IIA, and stage IIB CTCL mycosis fungoides (MF), and summarize toxic 
effects associated with the different topical treatments.

Entry Criteria

Disease Characteristics:

Histologically confirmed CTCL in stage IB, IIA, or IIB

Nodal biopsy required of lymphadenopathy patients

Measurable disease with one or more indicator lesions

Prior/Concurrent Therapy:

No concurrent nonprotocol topical therapy or systemic therapy allowed

Biologic therapy:
 No prior biologic therapy allowed

Chemotherapy:
 No prior chemotherapy allowed

Endocrine therapy:
 At least 4 weeks since prior topical or systemic steroids
 
Radiotherapy:
 No prior radiotherapy allowed

Surgery:
 At least 5 years disease free for cancers involving surgical treatment 

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2

Life expectancy:
 Estimated survival greater than 3 months

Hematopoietic:
 (2 weeks prior to study)
 WBC at least 3,000/mm3
 Granulocyte at least 1,000/mm3
 Platelet count at least 100,000/mm3


Hepatic:
 (2 weeks prior to study)
 Bilirubin no greater than 2.0 mg/dL

Renal:
 (2 weeks prior to study)
 Serum creatinine no greater than 2.0 mg/dL

Cardiovascular:
 No severe heart disease (NYHA classes III or IV) or cardiac pacemakers

Pulmonary:
 No peripheral venous insufficiency

Metabolic:
 No poorly controlled diabetes mellitus

Other:
 At least 1 week since prior antibiotic treatment; no acute infections
 Not HIV positive
 Effective contraception required of male and female patients
 No evidence of previous or concurrent second neoplasm, except:
  treated squamous cell or basal cell skin cancer
  treated carcinoma in situ of the cervix

Expected Enrollment

315 eligible patients will be accrued over 3.5 years with 2 years of follow-up.

Outline

Patients are randomized into two groups.  One group receives either psoralen 
with phototherapy (PUVA), mechlorethamine, or total skin electron beam 
radiation (TSE).  All others receive one topical therapy plus interferon 
alfa-2b. 

Oral methoxsalen is given 1.5 to 2 hours before light therapy.  PUVA 
treatments are given 3 times a week beginning at a low dosage with gradual 
escalation in exposure depending on skin tone, ability to tan, type of 
phototherapy unit used, and the presence of redness at the time of each 
subsequent treatment.

If complete remission (CR) occurs, PUVA continues for 2 months at the dose and 
frequency at which clearing has occurred.  PUVA can then be tapered to 
maintenance which will be given once weekly for 4 weeks, then every 2 weeks 
for a maximum of 2 years.

Mechlorethamine is administered daily to skin for 4 to 6 weeks.  If skin 
biopsy is negative and lesions have disappeared, treatments will be reduced to 
once weekly, and maintained for 2 years.

TSE is delivered to the entire skin surface over 4 to 10 weeks in 20 to 40 
treatments.  Soles of the feet are treated separately in at least 20 
treatments over 4 to 10 weeks.

Interferon alfa-2b is given SC 3 times a week and continues for 2 years in the 
absence of disease progression or excessive toxic effects.  

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Timothy Kuzel, MD, Protocol chair		Ph: 312-695-6180

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