Completed

Mitoxantrone Hydrochloride for AIDS-Related Kaposi's Sarcoma

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What is being tested

Mitoxantrone hydrochloride

Drug
Who is being recruted

Blood-Borne Infections+21

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorLederle Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This is a Phase II study focused on treating AIDS-related Kaposi's sarcoma, a type of cancer that can develop in people with AIDS. The study aims to understand the safety and effectiveness of a drug called Novantrone. It's important because it could potentially offer a new treatment option for those affected by this condition, improving their care and quality of life.

Principal SponsorLederle Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissueRetroviridae InfectionsRNA Virus InfectionsSarcomaSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsNeoplasms, Connective and Soft TissueAcquired Immunodeficiency SyndromeSarcoma, KaposiHIV Infections

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.)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Saint Luke's - Roosevelt Hosp Ctr

New York, United StatesOpen Saint Luke's - Roosevelt Hosp Ctr in Google Maps
CompletedOne Study Center