Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002259
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1991

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002259 on ClinicalTrials.gov Archive Site
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Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma

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

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Interventional
Phase 2
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Mitoxantrone hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

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.

Exclusion Criteria

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.

Prior Treatment:

Excluded:

  • Previous therapy consisting of more than one modality of therapy (e.g., chemotherapy plus radiotherapy or more than one form of chemotherapy regimen.)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002259
055B, 3-102
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Lederle Laboratories
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NIH AIDS Clinical Trials Information Service
August 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP