Overview

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

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Lederle Laboratories

Treatments:

Mitoxantrone

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.)