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Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Sarcoma, Kaposi, HIV Infections

Thank you

Trial Information

Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma


Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given
on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated
prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end
of the last treatment. Patients must agree to have one or more representative KS lesions
biopsied.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy
(e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.

- Therapy for tuberculosis, fungal, and herpes infections except with potentially
myelotoxic chemotherapy.

- Foscarnet for new episodes of cytomegalovirus infection.

- Colony-stimulating factors and erythropoietin.

Patients must have:

- Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:

- At least 25 mucocutaneous lesions.

- Ten or more new lesions in the prior month.

- Documented visceral disease with at least two accessible cutaneous lesions.

- Two accessible cutaneous lesions with edema.

- Documented anti-HIV antibody.

- No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma,
Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic
drugs).

- Life expectancy > 4 months.

NOTE:

- Patients who respond to therapy on this protocol, as well as those who fail the ABV
combination, are eligible to enter the Liposome Technology open trial using DOX-SL
alone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Clinically significant cardiac, hepatic, or renal disease.

- Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to
marked motor loss.

- Inability to comply with the study.

Concurrent Medication:

Excluded:

- Other cytotoxic chemotherapy.

- Ganciclovir.

Patients with the following prior conditions are excluded:

- Prior neoplasms treated with extensive chemotherapy that, in the investigator's
opinion, has led to irreversibly compromised bone marrow function.

- History of idiosyncratic or allergic reaction to bleomycin or vincristine.

Prior Medication:

Excluded:

- Prior anthracycline therapy.

- Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.

Prior Treatment:

Excluded:

- Radiation or electron beam therapy within the past 3 weeks.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

134A

NCT ID:

NCT00002318

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Vincristine
  • Sarcoma, Kaposi
  • Liposomes
  • Doxorubicin
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Bleomycin
  • Drug Carriers
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
Univ of Miami School of MedicineMiami, Florida  331361013
Henry Ford HospDetroit, Michigan  48202
Washington UnivSt Louis, Missouri  63108
Baylor College of MedicineHouston, Texas  77030
New York Univ Med CtrNew York, New York  10016
San Francisco Veterans Administration Med CtrSan Francisco, California  94121
East Bay AIDS CtrBerkeley, California  94705
H Lee Moffit Cancer Ctr and Research InstituteTampa, Florida  33612
Saint Vincent's Hosp and Med CtrNew York, New York  10011
Pacific Oaks Med GroupBeverly Hills, California  90211
Hematology - Oncology Med Group of San Fernando ValleyEncino, California  91436
Dr Becky MillerLos Angeles, California  90048
Apogee Med GroupSan Diego, California  92103
Kaiser Permanente Med CtrSan Francisco, California  94115
UCSFSan Francisco, California  941430324
UCSF - San Francisco Gen HospSan Francisco, California  94110
Dr Mahmoud MustafaWashington, District of Columbia  20037
American Med Research InstituteAtlanta, Georgia  30329
Infectious Disease Rsch Consortium of GA / SE Clin ResourcesAtlanta, Georgia  30345
Rush Presbyterian Med CollegeChicago, Illinois  60612
Illinois Masonic Med Ctr / The Cancer CtrChicago, Illinois  60657
Northwestern Med Faculty FoundationChicago, Illinois  60611
Roswell Park Cancer InstituteBuffalo, New York  14263
Graduate Hosp / Tuttleman Cancer CtrPhiladelphia, Pennsylvania  19146
Comprehensive Care CtrDallas, Texas  75235