Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
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ClinicalTrials.gov Identifier: NCT00002153 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections Lymphoproliferative Disorders | Drug: A-007 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 25 participants |
Primary Purpose: | Treatment |
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 |

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002153
United States, Louisiana | |
DEKK - TEC Inc | |
New Orleans, Louisiana, United States, 70119 |
ClinicalTrials.gov Identifier: | NCT00002153 History of Changes |
Other Study ID Numbers: |
247A DTI-006 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | May 1999 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents |
Additional relevant MeSH terms:
Disease HIV Infections Sarcoma Sarcoma, Kaposi Lymphoproliferative Disorders Pathologic Processes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Lymphatic Diseases Immunoproliferative Disorders |