Phase III Study of Topical Therapy of Psoralen With Phototherapy (PUVA), Nitrogen Mustard (Mechlorethamine HCL) Chemotherapy, or Total Skin Electron Beam (TSE) Alone vs One Topical Therapy Combined With Interferon Alfa-2b for Cutaneous T-Cell Lymphoma (CTCL)
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 III||Treatment||Completed||18 and over||NCI||ECOG-1495|
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.
Histologically confirmed CTCL in stage IB, IIA, or IIB Nodal biopsy required of lymphadenopathy patients Measurable disease with one or more indicator lesions
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
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
315 eligible patients will be accrued over 3.5 years with 2 years of follow-up.
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
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.