Completed

Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

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What is being tested

Doxorubicin hydrochloride (liposomal)

+ Filgrastim
+ Bleomycin sulfate
Drug
Who is being recruted

Sarcoma, Kaposi

+ HIV Infections
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: April 17, 2012
Sourced from a government-validated database.Claim as a partner

To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine. Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia. AS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen.

Official TitleComparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: April 17, 2012
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.
Design Details
120 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
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 sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Sarcoma, Kaposi
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Allowed: * G-CSF. * Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ). * PCP prophylaxis (required if CD4 count \< 200 cells/mm3). * Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex. * Up to 14 days of metronidazole. * Recombinant erythropoietin. Patients must have: * Documented HIV infection. * Advanced stage Kaposi's sarcoma. * No active acute opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Significant pulmonary insufficiency (unless due to pulmonary KS). * Significant cardiac insufficiency. * Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer. * Grade 2 or worse peripheral neuropathy. * Altered mental status that prevents informed consent. * Active Mycobacterium tuberculosis. * Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF). Concurrent Medication: Excluded: * GM-CSF. * Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine). * Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair). Concurrent Treatment: Excluded: * Radiation therapy to study marker lesions. Patients with the following prior condition are excluded: * Neuropsychiatric history. Prior Medication: Excluded: * Any anti-KS therapy within 21 days prior to study entry. * Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin. * Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry. PER AMENDMENT 11/29/95: * No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.



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 17 locations
Suspended
Alabama Therapeutics CRSBirmingham, United StatesSee the location
Suspended
USC CRSLos Angeles, United States
Suspended
UCLA CARE Center CRSLos Angeles, United States
Suspended
Ucsf Aids CrsSan Francisco, United States

Completed17 Study Centers