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A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma


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

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Trial Information

A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma


Twenty-eight patients (14 per cohort) receive daily vesnarinone at one of two doses. At
least seven patients at the lower dose must have completed 2 weeks of therapy before
subsequent patients are entered at the higher dose. Patients who successfully complete 16
weeks of treatment may receive maintenance therapy for the duration of the study
(approximately 12-18 months).

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.

- Acyclovir as acute treatment for herpes outbreaks.

Concurrent Treatment:

Allowed:

- Limited electron-beam radiation therapy to non-marker lesions for treatment of
Kaposi's sarcoma.

Patients must have:

- Documented HIV infection.

- Kaposi's sarcoma.

- No current constitutional signs of HIV disease or AIDS-defining conditions other than
Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Active malignancy other than Kaposi's sarcoma, cutaneous basal cell carcinoma, or in
situ carcinoma of the cervix.

- Current significant cardiac disease or anomaly (including prolonged QTC on EKG).

- Abnormal cardio-thoracic ratio on chest x-ray.

Concurrent Medication:

Excluded:

- Antiretroviral agents, including ddI, ddC, AZT, and d4T.

- Immunosuppressive agents.

- Investigational HIV drugs/therapies including vaccines (except those on treatment IND
for approved indications).

- Other anti-Kaposi's sarcoma/HIV drugs.

- Corticosteroids (other than topical).

- Biologic response modifiers.

- Megestrol acetate.

- Agents known to cause neutropenia.

- Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg
sulfamethoxazole thrice weekly.

- Cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

- Radiation therapy including electron beam irradiation (other than limited
electron-beam radiation to non-marker lesions for treatment of Kaposi's sarcoma).

Patients with the following prior conditions are excluded:

- Prior history of significant cardiac disease or anomaly.

- History of agranulocytosis or severe grade 3 drug-induced neutropenia or documented
abnormalities in granulocyte function.

Prior Medication:

Excluded:

- AZT within 14 days prior to study entry.

- Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.

Excluded within 30 days prior to study entry:

- Interferon.

- Biologic response modifiers.

- Cytotoxic chemotherapy.

Prior Treatment:

Excluded within 30 days prior to study entry:

- Blood or cellular blood product. Active illicit drug abuse (specifically cocaine,
amyl nitrate, heroin, or other cardioactive agents).

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:

234D

NCT ID:

NCT00002131

Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Antiviral Agents
  • vesnarinone
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

Northwestern Univ Med SchoolChicago, Illinois  60611
UCLA School of MedicineLos Angeles, California  900121973