Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma and lymphoproliferative disorders.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DEKK-TEC, Inc.

Criteria

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.