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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002153

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: May 1999

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
Official Title ^ICMJE	Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
Brief Summary	To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma and lymphoproliferative disorders.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Primary Purpose: Treatment
Condition ^ICMJE	Sarcoma, Kaposi HIV Infections Lymphoproliferative Disorders
Intervention ^ICMJE	Drug: A-007
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002153
Other Study ID Numbers ^ICMJE	247A, DTI-006
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	DEKK-TEC, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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