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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoma, Kaposi; HIV Infections

Intervention: Mitoxantrone hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Lederle Laboratories

Summary

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

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.)

Locations and Contacts

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10019, United States
Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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