A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.
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ClinicalTrials.gov Identifier: NCT00002093 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Daunorubicin (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma. |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- HIV infection.
- Advanced Kaposi's sarcoma.
Prior Medication:
Allowed:
- Prior intralesional vinblastine.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Acute intercurrent infection other than genital herpes.
- Uncompensated cardiovascular, hepatic, renal, or pulmonary disease unrelated to Kaposi's sarcoma.
- Symptomatic peripheral neuropathy.
- Any condition that compromises ability to give informed consent or complete the study.
Concurrent Medication:
Excluded:
- Concurrent ganciclovir.
Patients with the following prior conditions are excluded:
- Symptomatic AIDS-defining opportunistic infection within 2 weeks of entry.
- History of malignancy other than Kaposi's sarcoma, basal cell carcinoma, or carcinoma in situ of the cervix.
Prior Medication:
Excluded:
- Prior systemic chemotherapy.
- Intralesional therapies within 7 days prior to study entry.
- Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry.
- Interferon preparations (alpha or beta) within 28 days prior to study entry.
Prior Treatment:
Excluded within 7 days prior to study entry:
- Radiation.
- Local therapies (e.g., cryotherapy).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002093
United States, Arizona | |
Univ of Arizona / Arizona Cancer Ctr | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Kenneth Norris Jr Cancer Hosp | |
Los Angeles, California, United States, 90033 | |
Desert Hosp Comprehensive Cancer Ctr | |
Palm Springs, California, United States, 92262 | |
Saint Francis Mem Hosp | |
San Francisco, California, United States, 94109 | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
United States, Colorado | |
Denver Gen Hosp | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Univ of Miami Dept of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
New England Deaconess Hosp | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, Oregon | |
Kaiser Permanente Med Ctr | |
Portland, Oregon, United States, 97227 | |
United States, Texas | |
Dr Edward Stool | |
Houston, Texas, United States, 77004 |
ClinicalTrials.gov Identifier: | NCT00002093 |
Other Study ID Numbers: |
121A 103-09 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | March 1996 |
Vincristine Sarcoma, Kaposi Liposomes Doxorubicin |
Acquired Immunodeficiency Syndrome Bleomycin Daunorubicin Drug Carriers |
Sarcoma, Kaposi Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Virus Diseases Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Doxorubicin Liposomal doxorubicin Daunorubicin |
Bleomycin Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |