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Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
This study has been completed.

First Received on November 2, 1999.   Last Updated on March 1, 2011   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Sequus Pharmaceuticals
Amgen
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001059
  Purpose

To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life.

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.


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Doxorubicin hydrochloride (liposomal)
Drug: Filgrastim
Drug: Bleomycin sulfate
Drug: Vincristine sulfate
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 120
Primary Completion Date: August 1998 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001059

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Denver Dept of Health and Hosps
Denver, Colorado, United States, 80262
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Hawaii
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Illinois Masonic Med Ctr
Chicago, Illinois, United States, 606575147
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Massachusetts
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, New York
Mid - Hudson Care Ctr
Albany, New York, United States, 122083479
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States, 122083479
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Mount Sinai Med Ctr
New York, New York, United States, 10029
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
Sequus Pharmaceuticals
Amgen
Investigators
Study Chair: Mitsuyasu R
Study Chair: Krown S
Study Chair: Von Roenn JH
  More Information

Additional Information:
Publications:
Mitsuyasu R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997;16:A191

ClinicalTrials.gov Identifier: NCT00001059     History of Changes
Other Study ID Numbers: ACTG 286
Study First Received: November 2, 1999
Last Updated: March 1, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vincristine
Sarcoma, Kaposi
Liposomes
Doxorubicin
Drug Therapy, Combination
Granulocyte Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
Bleomycin
Drug Carriers

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Bleomycin
Doxorubicin
Vincristine
Lenograstim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on February 12, 2012