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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 to 79	NCI	UARIZ-8567 NCI-T85-0215D, T85-0215

Objectives

I.  Determine whether the drug combination of 13-cis retinoic acid/recombinant 
alpha interferon has antineoplastic effects in the treatment of mycosis 
fungoides (cutaneous T-cell lymphoma).
II.  Determine the toxic effects of the drug combination in mycosis fungoides.
III.  Obtain information on specific immunologic functions prior to, during, 
and after treatment of mycosis fungoides with the drug regimen.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients more than 18 and less than 
80 years of age with objectively evaluable mycosis fungoides, Stage II 
(limited or generalized plaques with adenopathy or cutaneous tumors with or 
without adenopathy without histologic involvement of lymph nodes or viscera), 
III (generalized erythroderma with or without adenopathy and without 
histologic involvement of lymph nodes or viscera), or IV (histologic 
involvement of lymph nodes or viscera with any skin lesion with or without 
adenopathy).  Patients may not have had any prior retinoid or interferon 
therapy; previous treatment with systemic chemotherapy, topical therapy, 
electron beam irradiation, PUVA, or systemic steroids is allowed but may not 
have been given within 4 weeks of entry.  Treatment with topical steroids must 
cease at least 2 weeks prior to entry.  Patients must be ambulatory with an 
expected survival of more than 10 weeks; an ECOG performance status of 2 or 
better, adequate renal, hepatic, and hematologic function (serum creatinine 
1.8 or less, bilirubin no more than 1.4, WBC at least 3,000, granulocytes at 
least 1,000, platelets 100,000 or more), and a serum calcium of no more than 
12 mg/dl are required.  Patients with prior or current heart disease, severe 
intercurrent infection, a history of seizure disorder and/or CNS metastases, 
or a history of malignancy (except noninvasive cutaneous carcinoma or 
carcinoma in situ) are not eligible.  Patients must not have had surgery 
within the 4 weeks prior to entry unless they have fully recovered.  Pregnant 
or lactating women are not eligible, and fertile men and women must be using 
effective contraception.  The following conditions exclude:  treatment with 
tetracycline or minocycline, a sensitivity to parabens, neurological or 
psychiatric disorders, hypertriglyceridemia (or a family history of the same), 
concomitant vitamin A therapy, or a history of hypervitaminosis A.  The use of 
aspirin or non-steroidal anti-inflammatory agents is not allowed; 
acetaminophen, codeine, and propoxyphene (not Darvon compound or Darvon with 
ASA) may be given at the discretion of the principal investigator.

Expected Enrollment

6-15 patients will be required for the Phase I portion of the study; a total 
of 25 evaluable patients will be required for the Phase II portion of the study.

Outline

Nonrandomized study.
Induction and Maintenance.  Single-agent Chemotherapy plus Single-agent 
Immunotherapy.  13-cis Retinoic Acid, RO-43780, 13-cis RA; plus recombinant 
alpha interferon, rIFN-alphaA, Roferon-A.

Trial Contact Information

Trial Lead Organizations

Arizona Cancer Center at University of Arizona Health Sciences Center

Frank Meyskens, MD, FACP, Protocol chair		Ph: 714-456-6310 Email: flmeyske@uci.edu