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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

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.

Inclusion 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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

121A

NCT ID:

NCT00002093

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Vincristine
  • Sarcoma, Kaposi
  • Liposomes
  • Doxorubicin
  • Acquired Immunodeficiency Syndrome
  • Bleomycin
  • Daunorubicin
  • Drug Carriers
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

George Washington Univ Med CtrWashington, District of Columbia  20037
Northwestern Univ Med SchoolChicago, Illinois  60611
New England Deaconess HospBoston, Massachusetts  02215
New York Univ Med CtrNew York, New York  10016
Univ of Arizona / Arizona Cancer CtrTucson, Arizona  85724
Kenneth Norris Jr Cancer HospLos Angeles, California  90033
Desert Hosp Comprehensive Cancer CtrPalm Springs, California  92262
Davies Med CtrSan Francisco, California  94114
Saint Francis Mem HospSan Francisco, California  94109
Denver Gen HospDenver, Colorado  802044507
Univ of Miami Dept of MedicineMiami, Florida  33136
Kaiser Permanente Med CtrPortland, Oregon  97227
Dr Edward StoolHouston, Texas  77004