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

Sponsor
Lederle Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00002259
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Mitoxantrone hydrochloride
 Phase 2

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Luke's - Roosevelt Hosp Ctr New York New York United States 10019

    Sponsors and Collaborators

    • Lederle Laboratories

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002259
    Other Study ID Numbers:
    • 055B
    • 3-102
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Aug 1, 1991
    Keywords provided by , ,
    Mitoxantrone
    Acquired Immunodeficiency Syndrome
    Additional relevant MeSH terms:
    Sarcoma, Kaposi
    Sarcoma
    Mitoxantrone

    Study Results

    No Results Posted as of Jun 24, 2005