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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
Official Title ^ICMJE	Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
Brief Summary	To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison, Efficacy Study
Condition ^ICMJE	Sarcoma, Kaposi HIV Infections
Intervention ^ICMJE	Drug: Mitoxantrone hydrochloride
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002259
Responsible Party
Study ID Numbers ^ICMJE	055B, 3-102
Study Sponsor ^ICMJE	Lederle Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	August 1991
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP