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

Lederle Laboratories1 个研究点分布在 1 个国家开始时间: 2001年8月31日最近更新: 2005年6月24日

适应症

试验速览

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

•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.

•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:
•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:
•More than one form of chemotherapy regimen.
•Doxorubicin therapy > 300 mg/m
•Prior Treatment:
•Previous therapy consisting of more than one modality of therapy (e.g., chemotherapy plus radiotherapy or more than one form of chemotherapy regimen.)

发起方

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