Sarcoma, KaposiPhase 2NCT00002188
A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma
A Phase 2 study testing Alitretinoin in people with Sarcoma, Kaposi and HIV Infections, run by Anderson Clinical Research.
Trial summary
The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS). 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?
- Alitretinoin
- How many people
- 27 participants
- Where
- No sites listed yet
- 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
- Patients must have:
- HIV positive status and histologic confirmation of KS.
- CD4 count > 200 mm3 (required of one-half of patients).
- Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.
- Acceptable organ system function.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.
- Prior Medication:
- Excluded:
- Systemic therapy for KS within 30 days.
Show all 10Show fewer
- Local or topical therapy for KS indicative lesions within 60 days.
- Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.
- Required:
- Approved antiretroviral therapy.
About this study
Official title: Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).
Read the detailed description
Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.
Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Alitretinoin
- Keywords
- AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Antineoplastic Agents
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlitretinoinDrug
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.
- 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
- Enrolment
- 27 participants
Sponsor and investigators
- Lead sponsor
- Anderson Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002188
- Sponsor's protocol ID
- 271A
- Other IDs
- L1057-28, 96ACR-LIG2
- Status last verified
- Aug 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
- ClinicalTrials.gov ID
- NCT00002188
- Acronym / sponsor ID
- 271A
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Antineoplastic Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants
- Lead sponsor
- Anderson Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Ligand Pharmaceuticals
- 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.
The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).
Detailed description
Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.
Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV positive status and histologic confirmation of KS.
- CD4 count > 200 mm3 (required of one-half of patients).
- Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.
- Acceptable organ system function.
Key exclusion criteria (10 listed)
- Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.
- Systemic therapy for KS within 30 days.
- Local or topical therapy for KS indicative lesions within 60 days.
- Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.
- Approved antiretroviral therapy.
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 |
|---|---|---|
| Alitretinoin | 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.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alitretinoin in people with Sarcoma, Kaposi and HIV Infections, run by Anderson Clinical Research.
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 5 inclusion and 10 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.
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?
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.