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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002153
• Other study ID #: 247A
• Secondary ID: DTI-006
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Lymphoproliferative Disorders
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• A-007

Locations

Country	Name	City	State
United States	DEKK - TEC Inc	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
DEKK-TEC, Inc.

Country where clinical trial is conducted

United States,