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Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mitsuyasu R

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 286

NCT ID:

NCT00001059

Start Date:

Completion Date:

August 1998

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Vincristine
  • Sarcoma, Kaposi
  • Liposomes
  • Doxorubicin
  • Drug Therapy, Combination
  • Granulocyte Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Bleomycin
  • Drug Carriers
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

Alabama Therapeutics CRSBirmingham, Alabama  35294
UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
Ucsf Aids CrsSan Francisco, California  
University of Colorado Hospital CRSAurora, Colorado  80262
Univ. of Miami AIDS CRSMiami, Florida  33136
Univ. of Hawaii at Manoa, Leahi Hosp.Honolulu, Hawaii  96816
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Massachusetts General Hospital ACTG CRSBoston, Massachusetts  02114
Beth Israel Deaconess - East Campus A0102 CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
Washington U CRSSt. Louis, Missouri  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Queens Med. Ctr.Honolulu, Hawaii  96816