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

L

Lederle Laboratories

Status and phase

Completed
Phase 2

Conditions

Sarcoma, Kaposi
HIV Infections

Treatments

Drug: Mitoxantrone hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002259
3-102
055B

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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