Sarcoma, KaposiNCT00002226
Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
A study testing SU5416 in people with Sarcoma, Kaposi and HIV Infections, run by SUGEN at 4 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors. 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?
- SU5416
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- You may be eligible for this study if you:
- Are at least 18 years old.
- Are HIV-positive.
- Have KS with at least 5 skin lesions.
- Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy.
- Agree to use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have had surgery within 4 weeks of study entry.
- Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry.
- Have pulmonary KS (KS in your lungs).
- Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers.
- Are allergic to Cremophor.
- Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy).
- Are pregnant.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Norris Cancer Ctr / USC
Los Angeles, California, 90033
UCLA Care Ctr / Ctr for Hlth Sciences
Los Angeles, California, 900951793
New York Univ Med Ctr
New York, New York, 10016
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
About this study
Official title: A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma
The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.
Read the detailed description
Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- SU5416
- Keywords
- Skin Neoplasms, Sarcoma, Kaposi, Antineoplastic Agents
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU5416Drug
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 N/A
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- SUGEN
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002226
- Sponsor's protocol ID
- 294A
- Other IDs
- 5416.003
- Status last verified
- Jun 2000
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Gill P, Arasteh K, Jacobs M, Friedman-Kiel A, Miles S, Gracey S, Hannah A, Langecker P. A multicenter, dose-escalating study in patients with AIDS-related Kaposi's Sarcoma 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29
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 Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00002226
- Acronym / sponsor ID
- 294A
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Skin Neoplasms, Sarcoma, Kaposi, Antineoplastic Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- SUGENIndustry (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.
The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.
Detailed description
Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.
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 (6 listed)
- Are at least 18 years old.
- Are HIV-positive.
- Have KS with at least 5 skin lesions.
- Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy.
- Agree to use effective methods of birth control during the study.
Key exclusion criteria (8 listed)
- Have had surgery within 4 weeks of study entry.
- Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry.
- Have pulmonary KS (KS in your lungs).
- Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers.
- Are allergic to Cremophor.
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 |
|---|---|---|
| SU5416 | 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.
- BackgroundGill P, Arasteh K, Jacobs M, Friedman-Kiel A, Miles S, Gracey S, Hannah A, Langecker P. A multicenter, dose-escalating study in patients with AIDS-related Kaposi's Sarcoma 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SU5416 in people with Sarcoma, Kaposi and HIV Infections, run by SUGEN at 4 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 6 inclusion and 8 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 4 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.
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 NCT00002226, 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.