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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002259

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: August 1991

History of Changes

Purpose

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

Condition	Intervention	Phase
Sarcoma, Kaposi HIV Infections	Drug: Mitoxantrone hydrochloride	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Kaposi Sarcoma

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002259

Locations


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

Sponsors and Collaborators

Lederle Laboratories

More Information


ClinicalTrials.gov Identifier:	NCT00002259 History of Changes
Other Study ID Numbers:	055B 3-102
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:


Mitoxantrone Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:


HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms	Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Mitoxantrone Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2017

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