Sarcoma, KaposiPhase 2NCT00002131
A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
A Phase 2 study testing Vesnarinone in people with Sarcoma, Kaposi and HIV Infections, run by Otsuka America Pharmaceutical at 2 sites in United States.
Trial summary
To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Kaposi, HIV Infections
- What is being tested?
- Vesnarinone
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
- Acyclovir as acute treatment for herpes outbreaks.
- Concurrent Treatment:
- Allowed:
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- 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.
Who cannot join
- 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:
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Univ Med School
Chicago, Illinois, 60611
UCLA School of Medicine
Los Angeles, California, 900121973
About this study
To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.
Read the 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
- Being tested
- Vesnarinone
- Keywords
- Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VesnarinoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, KaposiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Otsuka America Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002131
- Sponsor's protocol ID
- 234D
- Other IDs
- 22-93-254
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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)
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00002131
- Acronym / sponsor ID
- 234D
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- Otsuka America PharmaceuticalIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
- Acyclovir as acute treatment for herpes outbreaks.
- Limited electron-beam radiation therapy to non-marker lesions for treatment of Kaposi's sarcoma.
- Documented HIV infection.
- Kaposi's sarcoma.
Key exclusion criteria (34 listed)
- 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.
- Antiretroviral agents, including ddI, ddC, AZT, and d4T.
- Immunosuppressive agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vesnarinone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundPetit 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vesnarinone in people with Sarcoma, Kaposi and HIV Infections, run by Otsuka America Pharmaceutical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.