Malignant MesotheliomaPhase 2NCT00006014
SU5416 in Treating Patients With Malignant Mesothelioma
A Phase 2 study testing semaxanib in people with Malignant Mesothelioma, run by National Cancer Institute (NCI) at 10 sites in United States.
Trial summary
Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- semaxanib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2000to Feb 2009
- 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:
- Histologically or cytologically proven malignant mesothelioma (epithelial, sarcomatoid, or mixed subtype) that is not amenable to surgery or radiotherapy
- Measurable disease
- At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
- Pleural effusions and ascites are not considered measurable lesions
- Only site of measurable disease must not be located within prior radiotherapy port
- Lesion must be accessible for biopsy
- History of previously treated CNS metastasis allowed if:
- Neurologically stable
- No requirement for IV or oral steroids or IV anticonvulsants
- No active or residual disease by brain CT or MRI scan
- Patients with neurologic signs or symptoms suggestive of CNS metastasis must have a negative brain CT or MRI scan
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: WHO 0-2
- Life expectancy: At least 12 weeks
- WBC at least 3,000/mm3
- Platelet count at least 75,000/mm3
- Bilirubin no greater than 1.5 mg/dL
- SGOT and SGPT no greater than 2.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
- No uncompensated coronary artery disease on electrocardiogram or physical examination
- No history of myocardial infarction or severe/unstable angina within the past 6 months
- No severe peripheral vascular disease associated with diabetes mellitus
- No deep vein or arterial thrombosis within the past 3 months
- No pulmonary embolism within the past 3 months
- No significant uncontrolled underlying medical or psychiatric illness
- No serious active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Patients are not considered to have active malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse
- No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel
PRIOR CONCURRENT THERAPY:
- No more than 1 prior systemic chemotherapy regimen
- At least 4 weeks since prior systemic chemotherapy and recovered
- Prior intrapleural cytotoxic agents (including bleomycin) allowed
- No concurrent chemotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- At least 30 days since prior investigational drug and recovered
- No concurrent investigational drug
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
Evanston Northwestern Health Care
Evanston, Illinois, 60201
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46885-5099
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
About this study
Official title: A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma
Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate, median and overall survival, and time to progression in patients with unresectable malignant mesothelioma treated with SU5416.
II. Determine the effect of SU5416 on surrogate biologic endpoints, including microvessel density, tissue proliferative index, apoptosis, vascular endothelial growth factor levels, and tumor perfusion measured by MRI in these patients.
III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 21-45 patients will be accrued for this study within 18-24 months.
- Conditions
- Malignant Mesothelioma
- Being tested
- semaxanib
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma
- Medical subject headings
- Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaxanibDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: semaxanib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2004 (estimated)
- Study startAug 2000
- Primary completionFeb 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hedy L. Kindler, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006014
- Sponsor's protocol ID
- NCI-2012-02351
- Other IDs
- UCCRC-10409, UCCRC-NCI-44, NCI-44, CDR0000068023
- Status last verified
- Feb 2009
- First submitted
- 5 Jul 2000
- Last updated
- 3 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT00006014
- Acronym / sponsor ID
- NCI-2012-02351
- Conditions
- Malignant Mesothelioma
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2000
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Feb 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.
Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor.
Detailed description
OBJECTIVES:
- Determine the objective response rate, median and overall survival, and time to progression in patients with unresectable malignant mesothelioma treated with SU5416.
II. Determine the effect of SU5416 on surrogate biologic endpoints, including microvessel density, tissue proliferative index, apoptosis, vascular endothelial growth factor levels, and tumor perfusion measured by MRI in these patients.
III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 21-45 patients will be accrued for this study within 18-24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: semaxanibPatients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. |
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 | Arm I |
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 3 Jun 2013.
Related trials for Malignant Mesothelioma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
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.
Hedy L. Kindler, MD study chair
University of Chicago
10 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 semaxanib in people with Malignant Mesothelioma, run by National Cancer Institute (NCI) at 10 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 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 3 Jun 2013.