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

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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

Key facts

Study ID

NCT00002259

Run by

Lederle Laboratories

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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