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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

Primary Purpose

Sarcoma, Kaposi, HIV Infections, Lymphoproliferative Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
A-007
Sponsored by
DEKK-TEC, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • DEKK - TEC Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
DEKK-TEC, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00002153
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
DEKK-TEC, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections, Lymphoproliferative Disorders
Keywords
Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
A-007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
DEKK - TEC Inc
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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