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

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ClinicalTrials.gov Identifier: NCT00002259
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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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
Sarcoma, Kaposi HIV Infections Drug: Mitoxantrone hydrochloride Phase 2

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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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ClinicalTrials.gov Identifier: NCT00002259     History of Changes
Other Study ID Numbers: 055B
3-102
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 1991

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