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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mitoxantrone hydrochloride
Sponsored by
Lederle Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Mitoxantrone, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Saint Luke's - Roosevelt Hosp Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Lederle Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00002259
Brief Title
Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
Official Title
Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lederle Laboratories

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Mitoxantrone, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mitoxantrone hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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