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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.
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
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002153     History of Changes
Other Study ID Numbers: 247A, DTI-006
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Disease
HIV Infections
Lymphoproliferative Disorders
Sarcoma
Sarcoma, Kaposi
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Immunoproliferative Disorders
Lentivirus Infections
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014