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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002259
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sarcoma, Kaposi

Keywords

Mitoxantrone, Acquired Immunodeficiency Syndrome

Brief summary

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

Interventions

DRUGMitoxantrone hydrochloride

Sponsors

Lederle Laboratories
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026