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

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.)