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



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

For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Lederle Laboratories ,
Synopsis: To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.)
Total Enrollment: 

Location and Contact Information:

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


Additional Information:
Study ID Numbers:  055B;  3-102
Study Start Date: 
Record last reviewed: August 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002259

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