SarcomaPhase 2NCT00003419
Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
A Phase 2 study testing antiviral therapy in people with Sarcoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- antiviral therapy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Jun 1998to 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
DISEASE CHARACTERISTICS:
- Stage I-III (NYU) Kaposi's sarcoma that is slowly progressive
- Stable disease without progression in diameter of tumor or in number of lesions (less than 50% increase in 3 months)
- No progressive disease during or after treatment for Kaposi's sarcoma
- Level of viral load detectable independently from CD4+ cells
- No other active AIDS pathologies
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-3
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 1500/mm3
- Hemoglobin greater than 8 mg/dL
Hepatic:
- Bilirubin less than 2.5 times normal
- AST and ALT less than 5 times normal
- Alkaline phosphatase less than 2.5 times normal
Renal:
- Creatinine less than 2.5 times normal
Other:
- No prior malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer
- No active cytomegalovirus, herpes simplex 1 or 2, or herpes zoster infection requiring treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other
- No prior antiretroviral therapy OR
- No prior highly active antiretroviral therapy (HAART)
- No concurrent acyclovir, ganciclovir, foscarnet, or cidofovir
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)
RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma.
PURPOSE: This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposi's sarcoma.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of highly active antiretroviral therapy (HAART) in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposi's sarcoma.
OUTLINE: Patients receive therapy consisting of nucleoside analogues (RTI) and protease inhibitors (PI). Patients may receive either 2 RTIs or 2 RTIs plus 2 PIs. Treatment continues for 12 weeks, then progression is assessed.
Patients with stable or regressing Kaposi's sarcoma (KS) with a viral load of greater than 500 copies of RNA/mL may continue with the therapy (if the viral load has decreased by greater than 2 logs) or may modify therapy (if the viral load has decreased less than 2 logs). Patients with progressive disease may begin chemotherapy but continue to receive the antiretroviral therapy. Treatment continues for at least 48 weeks.
Patients are followed every 8 weeks until week 48.
PROJECTED ACCRUAL: This study will accrue a total of 14-25 patients.
- Conditions
- Sarcoma
- Being tested
- antiviral therapy
- Keywords
- AIDS-related Kaposi sarcoma
- Medical subject headings
- Sarcoma, AIDS-related Kaposi sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiviral therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Investigators
- Umberto Tirelli, MD, Study chair, Centro di Riferimento Oncologico - Aviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003419
- Sponsor's protocol ID
- CDR0000066438
- Other IDs
- ITA-GICAT-POS2, EU-97019
- Status last verified
- Nov 2001
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00003419
- Acronym / sponsor ID
- CDR0000066438
- Conditions
- Sarcoma
- Keywords
- AIDS-related Kaposi sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- Jun 1998
- First posted
- 27 Jan 2003 (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.
RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma.
PURPOSE: This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposi's sarcoma.
Detailed description
OBJECTIVES:
- Determine the efficacy of highly active antiretroviral therapy (HAART) in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposi's sarcoma.
OUTLINE: Patients receive therapy consisting of nucleoside analogues (RTI) and protease inhibitors (PI). Patients may receive either 2 RTIs or 2 RTIs plus 2 PIs. Treatment continues for 12 weeks, then progression is assessed.
Patients with stable or regressing Kaposi's sarcoma (KS) with a viral load of greater than 500 copies of RNA/mL may continue with the therapy (if the viral load has decreased by greater than 2 logs) or may modify therapy (if the viral load has decreased less than 2 logs). Patients with progressive disease may begin chemotherapy but continue to receive the antiretroviral therapy. Treatment continues for at least 48 weeks.
Patients are followed every 8 weeks until week 48.
PROJECTED ACCRUAL: This study will accrue a total of 14-25 patients.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| antiviral therapy | Procedure or surgery | – |
Primary outcome
Efficacy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Umberto Tirelli, MD study chair
Centro di Riferimento Oncologico - Aviano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing antiviral therapy in people with Sarcoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Efficacy. It is what the study was designed to measure, not a finding.
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 20 Sep 2013.