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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.

Sponsored by: DEKK-TEC
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002153
  Purpose

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


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
Lymphoproliferative Disorders
Drug: A-007
Phase I

MedlinePlus related topics:   AIDS    Cancer    Kaposi's Sarcoma    Soft Tissue Sarcoma   

Drug Information available for:   A 007   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Efficacy Study
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   25

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002153

Locations
United States, Louisiana
DEKK - TEC Inc    
      New Orleans, Louisiana, United States, 70119

Sponsors and Collaborators
DEKK-TEC
  More Information


Study ID Numbers:   247A, DTI-006
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002153
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Skin Neoplasms  
Sarcoma, Kaposi  
Acquired Immunodeficiency Syndrome  
Antineoplastic Agents  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Skin Neoplasms
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Lymphatic Diseases
Kaposi sarcoma
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Lymphoproliferative Disorders
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Pathologic Processes
Slow Virus Diseases
Disease
Immune System Diseases
Neoplasms, Vascular Tissue
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on December 03, 2008




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