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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


Phase 1
21 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections, Lymphoproliferative Disorders

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Trial Information

Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

247A

NCT ID:

NCT00002153

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Lymphoproliferative Disorders
  • Skin Neoplasms
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoproliferative Disorders
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

DEKK - TEC Inc New Orleans, Louisiana  70119