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

NCT ID: NCT00002131

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL

Brief Summary

To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.

Detailed Description

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).

Conditions

Sarcoma, Kaposi; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Vesnarinone

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role: lead

Locations

UCLA School of Medicine

Los Angeles, California, United States

Northwestern Univ Med School

Chicago, Illinois, United States

Countries

United States

References

Petit RG, Miles S, Magpantay L, Mitsuyasu R. Vesnarinone inhibits AIDS-KS cells in culture. Int Conf AIDS. 1994 Aug 7-12;10(1):169 (abstract no PB0104)

Reference Type: BACKGROUND

Other Identifiers

22-93-254

Identifier Type: -

Identifier Source: secondary_id

234D

Identifier Type: -

Identifier Source: org_study_id