NCT00002259

Brief Summary

To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma.

Trial Health

80
On Track

Trial Health Score

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

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

August 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Sarcoma, KaposiHIV Infections

Keywords

MitoxantroneAcquired Immunodeficiency Syndrome

Interventions

Mitoxantrone hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have the following:
  • Biopsy proven Kaposi's sarcoma in advanced stages.
  • Positive HIV antibody, HIV culture or antigen capture or T4 cells \< 500 in a patient with AIDS risk factor.
  • Informed consent and availability for follow-up.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Uncontrolled opportunistic infection.
  • Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone.
  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Patients with the following are excluded:
  • Uncontrolled opportunistic infection.
  • Unable to give informed consent.
  • Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone.
  • Prior Medication:
  • Excluded:
  • More than one form of chemotherapy regimen.
  • Doxorubicin therapy \> 300 mg/m2.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Mitoxantrone

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 DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
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: 1991-08

Locations

US(1)