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A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma


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

Thank you

Trial Information

A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma


Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles.
Any patient who has not experienced unacceptable toxicity and who is deemed to be responding
to the study drug (no evidence of disease progression) is permitted to continue receiving
SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient
experiences either unacceptable toxicity or tumor progression, as defined in the protocol.

Inclusion Criteria


Inclusion Criteria

Patients may be eligible for this study if they:

- Are at least 18 years old.

- Have KS.

- Have taken paclitaxel, DaunoXome, or Doxil for KS and they have either not gotten
better or could not tolerate treatment therapy.

- Have 1 of the following symptoms for KS: 5 lesions (sores), generalized KS-related
edema (swelling) without sores, or KS-related edema of the arms and legs.

- Agree to use an effective method of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Are pregnant or breast-feeding.

- Are allergic to Cremophor.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

310B

NCT ID:

NCT00005931

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Skin Neoplasms
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents
  • Enzyme Inhibitors
  • SU 5416
  • Protein-Tyrosine Kinase
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location
Alison L. Hannah South San Francisco, California  94080