Sarcoma, KaposiPhase 2NCT00002167
Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
A Phase 2 study testing Tin ethyl etiopurpurin in people with Sarcoma, Kaposi and HIV Infections, run by Clinical Solutions at 6 sites in United States.
Trial summary
To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT. 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?
- Tin ethyl etiopurpurin
- How many people
- 78 participants
- Where
- 6 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
- Patients must have:
- Documentation of at least one biopsy-confirmed KS lesion.
- A minimum of 4 and no more than 36 KS lesions.
- All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and <= 40 mm in diameter of the longest bidimensional axis.
- ACTG disease state T(0) L(0) or (1) S(0) or (1).
- Life expectancy greater than 6 months.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active opportunistic infection or condition except thrush or herpes simplex virus infections.
- Advanced KS tumor stages including the presence of tumor associated edema or ulceration, extensive oral KS, or KS in other non-nodal viscera.
- Hematopoietic dysfunction.
- Coagulation dysfunction.
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- Hepatic dysfunction.
- Renal dysfunction.
- Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction.
- Pulmonary dysfunction.
- Sepsis.
- Known disorder of lipoprotein metabolism or clearance.
- Patients with the following prior conditions are excluded:
- History of allergic or hypersensitivity reactions to light, egg proteins or egg yolks, history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- Excluded within 7 days of therapy:
- Hematopoietic dysfunction.
- Coagulation dysfunction.
- Hepatic dysfunction.
- Renal dysfunction.
- Excluded within 3 months of therapy:
- Pulmonary dysfunction.
- Excluded within 6 months of therapy:
- Myocardial infarction.
- Prior Medication:
- Excluded:
- Intralesional chemotherapy within the past 12 weeks.
- Systemic chemotherapy or investigational drugs within the past 4 weeks.
- Prior Treatment:
- Excluded within 3 months prior to therapy:
- Local cryotherapy or surgery to study lesions.
- Systemic or topical photodynamic therapy agents.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Buffalo Gen Hosp / PDT Ctr
Buffalo, New York, 14203
Health One - Rocky Mountain Cancer Ctr
Denver, Colorado, 80218
Thompson Cancer Survival Ctr
Knoxville, Tennessee, 37916
Univ of Southern California / Los Angeles
Los Angeles, California, 90033
Cedars Sinai Med Ctr
Los Angeles, California, 90048
Univ of California / San Francisco / Dermatology
San Francisco, California, 94143
About this study
To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT.
Read the detailed description
All patients receive a single dose of SnET2 and are randomized to receive either PDT light treatment or no light treatment (control group). Patients are assessed prior to and at 4, 12 and 24 weeks following treatment, and are followed for 7 months.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Tin ethyl etiopurpurin
- Keywords
- Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Photochemotherapy, tin etiopurpurin, Radiation-Sensitizing Agents
- 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.
Tin ethyl etiopurpurinDrug
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
- Intervention model
- Parallel groups
- Enrolment
- 78 participants
Sponsor and investigators
- Lead sponsor
- Clinical Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002167
- Sponsor's protocol ID
- 261A
- Status last verified
- Apr 1999
- 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
- Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
- ClinicalTrials.gov ID
- NCT00002167
- Acronym / sponsor ID
- 261A
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Photochemotherapy, tin etiopurpurin, Radiation-Sensitizing Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- Clinical SolutionsIndustry (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 determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT.
Detailed description
All patients receive a single dose of SnET2 and are randomized to receive either PDT light treatment or no light treatment (control group). Patients are assessed prior to and at 4, 12 and 24 weeks following treatment, and are followed for 7 months.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documentation of at least one biopsy-confirmed KS lesion.
- A minimum of 4 and no more than 36 KS lesions.
- All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and <= 40 mm in diameter of the longest bidimensional axis.
- ACTG disease state T(0) L(0) or (1) S(0) or (1).
- Life expectancy greater than 6 months.
Key exclusion criteria (31 listed)
- Active opportunistic infection or condition except thrush or herpes simplex virus infections.
- Advanced KS tumor stages including the presence of tumor associated edema or ulceration, extensive oral KS, or KS in other non-nodal viscera.
- Hematopoietic dysfunction.
- Coagulation dysfunction.
- Hepatic dysfunction.
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 |
|---|---|---|
| Tin ethyl etiopurpurin | 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.
6 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 Tin ethyl etiopurpurin in people with Sarcoma, Kaposi and HIV Infections, run by Clinical Solutions at 6 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 31 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 6 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?
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.