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Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) 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

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Trial Information

Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.


Patients receive DOX-SL every 3 weeks for up to 20 cycles.

Inclusion Criteria


Inclusion Criteria

Patients must have:

- AIDS-related Kaposi's sarcoma that requires systemic chemotherapy.

- EITHER a medical indication for continuation of DOX-SL following treatment on another
DOX-SL protocol, OR no remaining treatment options other than DOX-SL.

Prior Medication:

Allowed:

- Prior anthracyclines.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Cardiac ejection fraction < 50 percent or clinically significant cardiac disease.

- Eligibility for a Liposomal Technology comparative protocol.

Concurrent Medication:

Excluded:

- Other cytotoxic chemotherapy.

Patients with the following prior condition are excluded:

History of idiosyncratic or allergic reaction to anthracyclines.

Prior Medication:

Excluded:

- Chemotherapy within the past 3 weeks.

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:

134D

NCT ID:

NCT00002147

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

Sequus Pharmaceutical IncMenlo Park, California  94025