Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
Lead SponsorDEKK-TEC, Inc.
StatusCompleted No Results Posted
Indication/ConditionSarcoma, Kaposi HIV Infections Lymphoproliferative Disorders
To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma and lymphoproliferative disorders.
Inclusion Criteria Concurrent Medication: Allowed: Maintenance antihormones, hormones, and glucocorticoids. Patients must have: Histologically proven metastatic cancer including Kaposi's sarcoma and lymphoproliferative disorders to the skin or cutaneous sites. NOTE: Primary basal or squamous cell cancer of the skin is allowed. Failed both primary and secondary chemotherapy and/or immunotherapy protocols. Measurable skin or cutaneous lesions. 4 Life expectancy of at least 20 weeks. Prior Medication: Required: Prior therapy for cutaneous lesions from Kaposi's sarcoma or lymphoproliferative disorders. Allowed: Prior maintenance steroids and hormone/antihormone therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active infections other than medically stable HIV infection. Active congestive heart failure, any persistent arrhythmia or transient serious arrhythmia (ventricular tachycardia, sinoatrial arrest, etc.), or progressive cardiomyopathy. Unstable blood pressure. Seizures or other CNS disorders. Severe unstable diabetes mellitus. Coagulopathies. Thrombotic disease. Any other medical conditions that would prevent completion of study or produce significant risk to patient. Concurrent Medication: Excluded: Concomitant chemotherapy or immunotherapy. Ongoing corticosteroid therapy (unless maintenance). Patients with the following prior conditions are excluded: History of active cardiopulmonary or respiratory disease. History of sun hypersensitivity and photosensitive dermatoses. History of allergy or hypersensitivity to cosmetics, toiletries, or other dermatological products.