Clinical trial NCT00002093: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Vincristine
Sarcoma, Kaposi
Liposomes
Doxorubicin
Acquired Immunodeficiency Syndrome
Bleomycin
Daunorubicin
Drug Carriers
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.


Eligibility criteria: 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Univ of Arizona / Arizona Cancer Ctr
state: Arizona
city: Los Angeles
country: United States
facility: Kenneth Norris Jr Cancer Hosp
state: California
city: Palm Springs
country: United States
facility: Desert Hosp Comprehensive Cancer Ctr
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: Denver
country: United States
facility: Denver Gen Hosp
state: Colorado
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Miami
country: United States
facility: Univ of Miami Dept of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Boston
country: United States
facility: New England Deaconess Hosp
state: Massachusetts
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: Portland
country: United States
facility: Kaiser Permanente Med Ctr
state: Oregon
city: Houston
country: United States
facility: Dr Edward Stool
state: Texas
Study officials:
References:
citation: Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. doi: 10.1200/JCO.1996.14.8.2353.
citation: Savage GE, Gable C, Motte K, Dixon C, Becker R. A pharmacoeconomic analysis of Kaposi's sarcoma patients based on a clinical trial of ABV vs. DaunoXome. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):32 (abstract no LBB6048)