NCT00002153

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Sarcoma, KaposiHIV InfectionsLymphoproliferative Disorders

Keywords

Skin NeoplasmsSarcoma, KaposiAcquired Immunodeficiency SyndromeAntineoplastic Agents

Interventions

A-007DRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DEKK - TEC Inc

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsLymphoproliferative DisordersSkin NeoplasmsAcquired Immunodeficiency Syndrome

Interventions

4,4'-dihydroxybenzophenone-2,4-dinitrophenylhydrazone

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-05

Locations

US(1)