Sarcoma, KaposiPhase 1NCT00002262
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
A Phase 1 study testing Tumor Necrosis Factor in people with Sarcoma, Kaposi and HIV Infections, run by University of California, San Francisco at 1 site in United States.
Trial summary
To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Sarcoma, Kaposi, HIV Infections
- What is being tested?
- Tumor Necrosis Factor
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.
- Minimum life expectancy of 3 months.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Clinically significant cardiac disease.
- Known hemorrhagic diathesis or active bleeding disorder.
- Clinically apparent vascular disease.
- Known lipoprotein disorders.
Show all 24Show fewer
- History of seizure disorder or central nervous system (CNS) metastasis.
- Additional malignancy.
- Concurrent Medication:
- Excluded:
- Cardiac agents.
- Anticoagulants.
- Thrombolytic agents.
- Nonsteroidal anti-inflammatory drugs.
- Corticosteroids.
- Aspirin.
- Vasodilators.
- Patients with the following are excluded:
- Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions.
- Prior Treatment:
- Excluded within 4 weeks of study entry:
- Chemotherapy.
- Radiotherapy.
- Immunotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
About this study
To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Tumor Necrosis Factor
- Keywords
- Skin Neoplasms, Tumor Necrosis Factor, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, Skin Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Necrosis FactorDrug
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.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002262
- Sponsor's protocol ID
- 066A
- Other IDs
- 86-989
- Status last verified
- Dec 1988
- 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
- A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00002262
- Acronym / sponsor ID
- 066A
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Skin Neoplasms, Tumor Necrosis Factor, Acquired Immunodeficiency Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- 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 evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.
- Minimum life expectancy of 3 months.
Key exclusion criteria (24 listed)
- Clinically significant cardiac disease.
- Known hemorrhagic diathesis or active bleeding disorder.
- Clinically apparent vascular disease.
- Known lipoprotein disorders.
- History of seizure disorder or central nervous system (CNS) metastasis.
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 |
|---|---|---|
| Tumor Necrosis Factor | 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tumor Necrosis Factor in people with Sarcoma, Kaposi and HIV Infections, run by University of California, San Francisco at 1 site 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 3 inclusion and 24 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.