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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

D

DEKK-TEC

Status and phase

Completed
Phase 1

Conditions

Sarcoma, Kaposi
HIV Infections
Lymphoproliferative Disorders

Treatments

Drug: A-007

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002153
DTI-006
247A

Details and patient eligibility

About

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

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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