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A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Doxorubicin hydrochloride (liposomal)
Sponsored by
Sequus Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month. Maintenance therapy for tuberculosis, fungal, and herpes infections. Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. Foscarnet or ganciclovir for CMV infection. Colony stimulating factors and erythropoietin. Patients must have: Moderate to severe AIDS-related Kaposi's sarcoma. Documented anti-HIV antibody. No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). NOTE: Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinically significant cardiac disease. Confusion or disorientation. Concurrent Medication: Excluded: Other cytotoxic cancer chemotherapy. Patients with the following prior conditions are excluded: Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function. History of idiosyncratic or allergic reaction to anthracyclines. History of major psychiatric illness. Prior Medication: Excluded within the past 4 weeks: Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol). Interferon treatment. Prior Treatment: Excluded within the past 3 weeks: Radiation or electron beam therapy.

Sites / Locations

  • East Bay AIDS Ctr
  • Pacific Oaks Med Group
  • Hematology - Oncology Med Group of San Fernando Valley
  • Dr Becky Miller
  • Apogee Med Group
  • UCSF - San Francisco Gen Hosp
  • Kaiser Permanente Med Ctr
  • UCSF
  • San Francisco Veterans Administration Med Ctr
  • UCSF
  • Pacific Oaks Med Group
  • Dr Mahmoud Mustafa
  • Univ of Miami School of Medicine
  • H Lee Moffit Cancer Ctr and Research Institute
  • American Med Research Institute
  • Infectious Disease Rsch Consortium of GA / SE Clin Resources
  • Northwestern Med Faculty Foundation
  • Rush Presbyterian Med College
  • Illinois Masonic Med Ctr / The Cancer Ctr
  • Henry Ford Hosp
  • Washington Univ
  • Roswell Park Cancer Institute
  • Saint Vincent's Hosp and Med Ctr
  • New York Univ Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Saint Luke's - Roosevelt Hosp Ctr
  • Mount Sinai Med Ctr
  • Graduate Hosp / Tuttleman Cancer Ctr
  • Comprehensive Care Ctr
  • Baylor College of Medicine
  • Houston Immunological Institute
  • Twelve Oaks Hosp
  • Virginia Mason Research Center / Clinical Trial Unit

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Sequus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002319
Brief Title
A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
Official Title
Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sequus Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.
Detailed Description
Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride (liposomal)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month. Maintenance therapy for tuberculosis, fungal, and herpes infections. Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. Foscarnet or ganciclovir for CMV infection. Colony stimulating factors and erythropoietin. Patients must have: Moderate to severe AIDS-related Kaposi's sarcoma. Documented anti-HIV antibody. No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). NOTE: Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinically significant cardiac disease. Confusion or disorientation. Concurrent Medication: Excluded: Other cytotoxic cancer chemotherapy. Patients with the following prior conditions are excluded: Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function. History of idiosyncratic or allergic reaction to anthracyclines. History of major psychiatric illness. Prior Medication: Excluded within the past 4 weeks: Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol). Interferon treatment. Prior Treatment: Excluded within the past 3 weeks: Radiation or electron beam therapy.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Pacific Oaks Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Hematology - Oncology Med Group of San Fernando Valley
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Dr Becky Miller
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Apogee Med Group
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
941430324
Country
United States
Facility Name
Pacific Oaks Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Dr Mahmoud Mustafa
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H Lee Moffit Cancer Ctr and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
American Med Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Infectious Disease Rsch Consortium of GA / SE Clin Resources
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Northwestern Med Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian Med College
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Masonic Med Ctr / The Cancer Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington Univ
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Graduate Hosp / Tuttleman Cancer Ctr
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Comprehensive Care Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Immunological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Twelve Oaks Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Virginia Mason Research Center / Clinical Trial Unit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Jablonowski H, Szelenyi H, Armbrecht C, Mauss S, Niederau C, Strohmeyer G. Liposomal doxorubicin--a new formulation for the treatment of Kaposi's sarcoma: a study on safety and efficacy in AIDS patients. Int Conf AIDS. 1993 Jun 6-11;9(1):397 (abstract no PO-B12-1573)
Results Reference
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A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

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