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

DEKK-TEC

Status and phase: Completed; Phase 1

Conditions: Sarcoma, Kaposi; HIV Infections; Lymphoproliferative Disorders

Treatments: Drug: A-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002153

DTI-006

247A

Details and patient eligibility

About

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

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.