Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002259 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Mitoxantrone hydrochloride | Phase 2 |
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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.)

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