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

Completed · Phase 1

Conditions studied: Sarcoma, Kaposi, HIV Infections, Lymphoproliferative Disorders

In brief

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

Key facts

Study ID

NCT00002153

Run by

DEKK-TEC, Inc.

People needed

25

Last updated by the study team

2005-06-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• DEKK - TEC Inc — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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