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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Sarcoma, Kaposi HIV Infections Lymphoproliferative Disorders

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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A-007

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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DEKK - TEC Inc

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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DTI-006

Identifier Type: -

Identifier Source: secondary_id

247A