Official Title

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

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    mitoxantrone ...
  • Study Participants

    None
To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Mitoxantrone hydrochloride

Criteria

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.)
No Results Posted