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Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma


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

Thank you

Trial Information

Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

134C

NCT ID:

NCT00002319

Start Date:

Completion Date:

Related Keywords:

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

Name

Location

Mem Sloan - Kettering Cancer Ctr New York, New York  10021
Saint Luke's - Roosevelt Hosp Ctr New York, New York  10025
Univ of Miami School of Medicine Miami, Florida  331361013
Mount Sinai Med Ctr New York, New York  10029
Henry Ford Hosp Detroit, Michigan  48202
Washington Univ St Louis, Missouri  63108
Baylor College of Medicine Houston, Texas  77030
New York Univ Med Ctr New York, New York  10016
San Francisco Veterans Administration Med Ctr San Francisco, California  94121
East Bay AIDS Ctr Berkeley, California  94705
Twelve Oaks Hosp Houston, Texas  77074
Virginia Mason Research Center / Clinical Trial Unit Seattle, Washington  98101
H Lee Moffit Cancer Ctr and Research Institute Tampa, Florida  33612
Saint Vincent's Hosp and Med Ctr New York, New York  10011
Pacific Oaks Med Group Beverly Hills, California  90211
Hematology - Oncology Med Group of San Fernando Valley Encino, California  91436
Dr Becky Miller Los Angeles, California  90048
Apogee Med Group San Diego, California  92103
Kaiser Permanente Med Ctr San Francisco, California  94115
UCSF San Francisco, California  941430324
UCSF - San Francisco Gen Hosp San Francisco, California  94110
Dr Mahmoud Mustafa Washington, District of Columbia  20037
American Med Research Institute Atlanta, Georgia  30329
Infectious Disease Rsch Consortium of GA / SE Clin Resources Atlanta, Georgia  30345
Rush Presbyterian Med College Chicago, Illinois  60612
Illinois Masonic Med Ctr / The Cancer Ctr Chicago, Illinois  60657
Northwestern Med Faculty Foundation Chicago, Illinois  60611
Roswell Park Cancer Institute Buffalo, New York  14263
Graduate Hosp / Tuttleman Cancer Ctr Philadelphia, Pennsylvania  19146
Comprehensive Care Ctr Dallas, Texas  75235
Houston Immunological Institute Houston, Texas  77054