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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Sarcoma, Kaposi HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Mitoxantrone hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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3-102

Identifier Type: -

Identifier Source: secondary_id

055B