SarcomaPhase 1NCT00003720
SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma
A Phase 1 study testing semaxanib in people with Sarcoma, run by Pfizer at 4 sites in United States.
Trial summary
RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related 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?
- semaxanib
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Jul 1998to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Biopsy proven Kaposi's sarcoma that is stable or progressing while receiving standard therapy HIV positive No severe pulmonary Kaposi's sarcoma Five measurable lesions of at least 10 mm or lesions present for at least 30 days OR KS-related generalized edema or edema of the extremities without evidence of active mucocutaneous lesions
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 750/mm3 without transfusion Hemoglobin at least 8.0 g/dL without transfusion Platelet count at least 50,000/mm3 without transfusion Hepatic: AST/ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL if concurrent indinavir therapy) Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant Fertile patients must use effective contraception No known allergy to Cremophor or Cremophor based drug product No concurrent uncontrolled serious infection such as: Pneumocystis carinii pneumonia Toxoplasma brain abscess CMV retinitis or colitis Cryptococcal meningitis Symptomatic Mycobacterium avium-intracellulare No other active malignancy except: Basal cell carcinoma of the skin Carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy for AIDS-related Kaposi's sarcoma At least 2 weeks since prior immunotherapy for AIDS-related Kaposi's sarcoma and recovered At least 2 weeks since prior epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent immunotherapy Chemotherapy: At least 2 weeks since prior chemotherapy for AIDS-related Kaposi's sarcoma and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy for AIDS-related Kaposi's sarcoma No concurrent hormonal therapy (including beta-HCG) Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No prior biopsy of measurable lesion Other: No prior laser therapy to measurable lesion Stable antiretroviral therapy for at least 2 weeks At least 3 weeks since other investigational drugs No concurrent local or topical therapy for disease No other concurrent investigational agents
Trial locations and contacts
4 sites in 1 country.
United States4 sites
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Kaplan Cancer Center
New York, New York, 10016
St. Francis Hospital
San Francisco, California, 94109
About this study
Official title: A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma
RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.
Read the detailed description
OBJECTIVES: I. Evaluate the safety and tolerability of SU5416 in patients with AIDS-related Kaposi's sarcoma. II. Determine the pharmacokinetics of this regimen in these patients. III. Evaluate the antitumor effects and biological activity of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients receive SU5416 by intravenous injection twice weekly for 4 weeks. Patients may continue treatment for a maximum of 1 year in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of SU5416 on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (MTD). Six additional patients are treated at the MTD. Patients are followed at 30 days after the last treatment, and every 3 months thereafter.
PROJECTED ACCRUAL: This study will accrue a maximum of 30 patients.
- Conditions
- Sarcoma
- Being tested
- semaxanib
- Keywords
- AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
- Medical subject headings
- Sarcoma, AIDS-related Kaposi sarcoma, Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaxanibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2004 (estimated)
- Study startJul 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.
- More trials run by PfizerThe 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
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison L. Hannah, MBBS, Study chair, SUGEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003720
- Sponsor's protocol ID
- SUGEN-SU5416.003
- Other IDs
- CDR0000066829, LAC-USC-17K981
- Status last verified
- Aug 2012
- First submitted
- 1 Nov 1999
- Last updated
- 23 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. 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
- NCT00003720
- Acronym / sponsor ID
- SUGEN-SU5416.003
- Conditions
- Sarcoma
- Keywords
- AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- First posted
- 16 Jun 2004 (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: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.
Detailed description
OBJECTIVES: I. Evaluate the safety and tolerability of SU5416 in patients with AIDS-related Kaposi's sarcoma. II. Determine the pharmacokinetics of this regimen in these patients. III. Evaluate the antitumor effects and biological activity of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients receive SU5416 by intravenous injection twice weekly for 4 weeks. Patients may continue treatment for a maximum of 1 year in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of SU5416 on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (MTD). Six additional patients are treated at the MTD. Patients are followed at 30 days after the last treatment, and every 3 months thereafter.
PROJECTED ACCRUAL: This study will accrue a maximum of 30 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 |
|---|---|---|
| semaxanib | 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 23 Aug 2012.
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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.
Alison L. Hannah, MBBS study chair
SUGEN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing semaxanib in people with Sarcoma, run by Pfizer 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?
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 23 Aug 2012. 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.
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 23 Aug 2012.