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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002259
• Other study ID #: 055B
• Secondary ID: 3-102
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1991
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Mitoxantrone hydrochloride

Locations

Country	Name	City	State
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Lederle Laboratories

Country where clinical trial is conducted

United States,