Recurrent High-Grade GliomasPhase 2NCT00271609
Bevacizumab for Recurrent Malignant Glioma
A Phase 2 study testing Bevacizumab in people with Recurrent High-Grade Gliomas and Malignant Gliomas, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progression by diminishing the supply of life-sustaining nutrients and oxygen the blood delivers to the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent High-Grade Gliomas, Malignant Gliomas
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with histologically proven intracranial malignant glioma will be eligible for this protocol.
- Malignant glioma include glioblastoma multiforme (GBM),
- gliosarcoma,
- anaplastic astrocytoma (AA),
- anaplastic oligodendroglioma (AO),
- anaplastic mixed oligoastrocytoma (AMO),
Show all 54Show fewer
- or malignant astrocytoma NOS (not otherwise specified).
- Patients must have evidence for tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
- This scan should be performed within 14 days prior to registration and on a fixed dose of steroids for at least 5 days.
- If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required.
- The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
- They have recovered from the effects of surgery.
- Residual disease following resection of recurrent tumor is not mandated for eligibility into the study.
- To best assess the extent of residual disease post-operatively, a CT/ MRI should be done:
- no later than 96 hours in the immediate post-operative period or
- at least 4 weeks post-operatively, and
- within 14 days of registration, and
- on a steroid dosage that has been stable for at least 5 days.
- If the 96 hour scan is more than 21 days before registration, the scan needs to be repeated.
- If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days.
- Patients must have progressed after radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be greater than or equal to 18 years old,
- and with a life expectancy greater than 8 weeks.
- Patients must have a Karnofsky performance status of greater than or equal to 60.
- Patients must have recovered from the toxic effects of prior therapy:
- 2 weeks from any investigational agent,
- 4 weeks from prior cytotoxic therapy,
- two weeks from vincristine,
- 6 weeks from nitrosoureas,
- 3 weeks from procarbazine administration,
- and 1 week for non-cytotoxic agents, e.g., interferon,
- tamoxifen,
- thalidomide,
- cis-retinoic acid, etc. (radiosensitizer does not count).
- Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
- Patients must have adequate bone marrow function (white blood count (WBC) -greater than or equal to 3,000/microliters,
- absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3,
- platelet count of greater than or equal to 100,000/mm^3,
- and hemoglobin greater than or equal to 10 gm/dl),
- adequate liver function (serum glutamic oxaloacetic transaminase (SGOT) and -bilirubin less than 2 times upper limit of normal (ULN)),
- and adequate renal function (creatinine less than 1.5 mg/dL and/or creatinine -clearance greater than or equal to 60 cc/min) before starting therapy.
- These tests must be performed within 14 days prior to registration. -Eligibility level for hemoglobin may be reached by transfusion.
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects.
- Males and females will be recruited with no preference to gender.
- No exclusion to this study will be based on race.
- Minorities will actively be recruited to participate.
- Urine protein should be screened by dipstick or urine analysis for Urine Protein Creatinine (UPC) ratio.
- For proteinuria greater than or equal to 1+ or urine protein:
- creatinine UPC ratio greater than 1.0,
- 24-hour urine protein should be obtained and the level should be less than 1000 mg for patient enrollment.
- Patients must practice adequate contraception
Who cannot join
- Patients who, in the view of the treating physician,
- have significant active cardiac,
- hepatic,
- renal,
- or psychiatric diseases are ineligible.
- No concurrent use of other standard chemotherapeutics or investigative agents.
Show all 37Show fewer
- Patients known to have a malignancy that has required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except non-melanoma skin cancer or carcinoma in-situ in the cervix).
- Patients who have an active infection.
- Pregnant (positive pregnancy test) or nursing women.
- Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy.
- Patients who have any disease that will obscure toxicity.
- Patients with evidence of acute intracranial/intratumoral hemorrhage on pre-study CT scan.
- Concurrent anti-coagulation or anti-platelet medication (including aspirin, -non-steroidal anti-inflammatories,
- cyclooxygenase 2 (COX-2) inhibitors).
- Serious or non-healing wound,
- ulcer
- or bone fracture
- History of abdominal fistula,
- gastrointestinal perforation
- or intra-abdominal abscess within 28 days
- Invasive procedures defined as follows:
- Major surgical procedure,
- open biopsy
- or significant traumatic injury within 28 days prior to Day 1 therapy
- Anticipation of need for major surgical procedures during the course of the study
- Core biopsy within 7 days prior to day 1 (D1) therapy
- Patients with clinically significant cardiovascular disease
- History of cerebrovascular accident (CVA) within 6 months
- Uncontrolled hypertension (greater than 150/100 mmHg)
- Myocardial infarction or unstable angina within 6 months
- New York Heart Association grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Unstable angina pectoris
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Prothrombin time (PT) international normalized ratio (INR) greater than 1.5
- Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas
Background:
Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progression by diminishing the supply of life-sustaining nutrients and oxygen the blood delivers to the tumor.
Read more
Bevacizumab is approved for treating colorectal cancer and has shown activity against brain tumor cells in laboratory and animal tests.
Objectives:
To examine the safety and side effects of bevacizumab in patients with recurrent brain tumors.
To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors.
Eligibility:
Patients 18 years of age and older with a brain tumor that continues to grow after receiving standard treatments.
Design:
Patients complete the following procedures during the study:
- Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles.
- Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end of the first treatment cycle, and as needed after that.
- Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96 hours after the first dose of bevacizumab in the first treatment cycle, and then every 4 weeks. One tube of blood for research is collected at the time of each MRI scan to look at specific cells.
- Physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks.
- Quality-of-life questionnaires every 4 weeks.
Read the detailed description
Background
- In vivo experiments have documented the ability of anti-vascular endothelial growth factor (VEGF) antibodies like bevacizumab to inhibit tumor growth in various preclinical tumor models, including gliomas.
- Given the pronounced neovasculature associated with over-expression of VEGF in malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, bevacizumab represents a potentially promising new therapeutic approach to these otherwise refractory tumors.
Objective
- To establish data regarding the anti-tumor activity of bevacizumab in patients with recurrent high-grade gliomas as determined by progression-free-survival.
- To obtain information regarding the safety of bevacizumab administered to patients with recurrent high-grade gliomas.
Eligibility
- Adult patients with histologically proven intracranial malignant glioma
- Patients must have evidence for tumor progression by magnetic resonance imaging (MRI) scan
- Patients must have progressed after radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry
Design
- Patients will be treated with bevacizumab by intravenous injection at a dose of 10mg/kg every two weeks on a 4-week cycle.
- Prior to the first dose of bevacizumab and at the completion of the first 4-weeks of treatment, patients will undergo a fludeoxyglucose 18F -positron emission tomography (FDG-PET) scan (in cycle one only and then as needed) and a MRI perfusion scan.
- Peripheral blood circulating endothelial progenitor cells will be collected at the time of each MRI-perfusion scan. Additionally, patients will undergo a MRI perfusion scan within 48-96 hours of their first dose of bevacizumab (in cycle one only).
- For patients who are clinically/neurologically stable and with stable or responding radiographic disease at the end of each treatment cycle, treatment will continue with bevacizumab every 2 weeks, repeating MRI-perfusion scans at the conclusion (e.g. prior to another administration of bevacizumab) of each 4 week cycle.
A total of 88 patients will be enrolled on this study.
- Conditions
- Recurrent High-Grade Gliomas, Malignant Gliomas
- Being tested
- Bevacizumab
- Keywords
- AVASTIN, Recurrence, Chemotherapy, Anti-Angiogenesis, Radiotherapy, Brain Tumor, Malignant Glioma
- Medical subject headings
- Glioma, Recurrence, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called rhuMAb VEGF
10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Anaplastic Glioma (AG) | Other | Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified) 10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes. Receives: Drug: Bevacizumab |
| Glioblastoma Multiforme (GBM) | Other | Glioblastoma multiforme Gliosarcoma 10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Progression Free Survival at 6 Months.
Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.
Measured: 6 months
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionMar 2011
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Recurrent High-Grade GliomasStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Teri Kreisl, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Teri Kreisl, M.D., Principal investigator, National Cancer Institute, National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271609
- Sponsor's protocol ID
- 060064
- Other IDs
- 06-C-0064
- Status last verified
- Apr 2014
- First submitted
- 31 Dec 2005
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.
PubMed 3107130Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.
PubMed 3001489Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.
PubMed 4093991Kreisl TN, Zhang W, Odia Y, Shih JH, Butman JA, Hammoud D, Iwamoto FM, Sul J, Fine HA. A phase II trial of single-agent bevacizumab in patients with recurrent anaplastic glioma. Neuro Oncol. 2011 Oct;13(10):1143-50. doi: 10.1093/neuonc/nor091. Epub 2011 Aug 24.
PubMed 21865400Odia Y, Shih JH, Kreisl TN, Fine HA. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014 Nov;120(2):431-40. doi: 10.1007/s11060-014-1571-6. Epub 2014 Aug 7.
PubMed 25098701
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00271609
- Acronym / sponsor ID
- 060064
- Conditions
- Recurrent High-Grade Gliomas, Malignant Gliomas
- Keywords
- AVASTIN, Recurrence, Chemotherapy, Anti-Angiogenesis, Radiotherapy, Brain Tumor, Malignant Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Jan 2006 (estimated)
- Results
- Posted 8 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. Inhibiting the formation of these blood vessels may slow or stop disease progression by diminishing the supply of life-sustaining nutrients and oxygen the blood delivers to the tumor.
Bevacizumab is approved for treating colorectal cancer and has shown activity against brain tumor cells in laboratory and animal tests.
Objectives:
To examine the safety and side effects of bevacizumab in patients with recurrent brain tumors.
To determine the anti-tumor activity of bevacizumab in patients with recurrent brain tumors.
Eligibility:
Patients 18 years of age and older with a brain tumor that continues to grow after receiving standard treatments.
Design:
Patients complete the following procedures during the study:
- Infusions of bevacizumab through a vein once every 2 weeks in 4-week treatment cycles.
- Positron emission tomography (PET) scan before the first dose of bevacizumab, at the end of the first treatment cycle, and as needed after that.
- Magnetic resonance imaging (MRI) scan before the first dose of bevacizumab, within 48-96 hours after the first dose of bevacizumab in the first treatment cycle, and then every 4 weeks. One tube of blood for research is collected at the time of each MRI scan to look at specific cells.
- Physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks.
- Quality-of-life questionnaires every 4 weeks.
Detailed description
Background
- In vivo experiments have documented the ability of anti-vascular endothelial growth factor (VEGF) antibodies like bevacizumab to inhibit tumor growth in various preclinical tumor models, including gliomas.
- Given the pronounced neovasculature associated with over-expression of VEGF in malignant gliomas, and abundant published data demonstrating the dependence of glioma growth on the maintenance and proliferation of this neovasculature, bevacizumab represents a potentially promising new therapeutic approach to these otherwise refractory tumors.
Objective
- To establish data regarding the anti-tumor activity of bevacizumab in patients with recurrent high-grade gliomas as determined by progression-free-survival.
- To obtain information regarding the safety of bevacizumab administered to patients with recurrent high-grade gliomas.
Eligibility
- Adult patients with histologically proven intracranial malignant glioma
- Patients must have evidence for tumor progression by magnetic resonance imaging (MRI) scan
- Patients must have progressed after radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry
Design
- Patients will be treated with bevacizumab by intravenous injection at a dose of 10mg/kg every two weeks on a 4-week cycle.
- Prior to the first dose of bevacizumab and at the completion of the first 4-weeks of treatment, patients will undergo a fludeoxyglucose 18F -positron emission tomography (FDG-PET) scan (in cycle one only and then as needed) and a MRI perfusion scan.
- Peripheral blood circulating endothelial progenitor cells will be collected at the time of each MRI-perfusion scan. Additionally, patients will undergo a MRI perfusion scan within 48-96 hours of their first dose of bevacizumab (in cycle one only).
- For patients who are clinically/neurologically stable and with stable or responding radiographic disease at the end of each treatment cycle, treatment will continue with bevacizumab every 2 weeks, repeating MRI-perfusion scans at the conclusion (e.g. prior to another administration of bevacizumab) of each 4 week cycle.
A total of 88 patients will be enrolled on this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anaplastic Glioma (AG) | Other | Drug: BevacizumabAnaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified) 10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes. |
| Glioblastoma Multiforme (GBM) | Other | Drug: BevacizumabGlioblastoma multiforme Gliosarcoma 10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (54 listed)
- Patients with histologically proven intracranial malignant glioma will be eligible for this protocol.
- Malignant glioma include glioblastoma multiforme (GBM),
- gliosarcoma,
- anaplastic astrocytoma (AA),
- anaplastic oligodendroglioma (AO),
Key exclusion criteria (37 listed)
- Patients who, in the view of the treating physician,
- have significant active cardiac,
- hepatic,
- renal,
- or psychiatric diseases are ineligible.
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 |
|---|---|---|
| BevacizumabAlso: rhuMAb VEGF10 mg/kg intravenously over 90 minutes every 2 weeks on a 28 day cycle. First dose is given over 90 minutes and subsequent doses are given over 30 minutes. | Drug | Anaplastic Glioma (AG), Glioblastoma Multiforme (GBM) |
Primary outcome
Percentage of Participants With Progression Free Survival at 6 Months.
Time frame: 6 months
Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.
Number of Participants With Adverse Events
Time frame: 5 years
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3107130Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.
- Background: PubMed 3001489Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.
- Background: PubMed 4093991Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.
- Results publication: PubMed 21865400Kreisl TN, Zhang W, Odia Y, Shih JH, Butman JA, Hammoud D, Iwamoto FM, Sul J, Fine HA. A phase II trial of single-agent bevacizumab in patients with recurrent anaplastic glioma. Neuro Oncol. 2011 Oct;13(10):1143-50. doi: 10.1093/neuonc/nor091. Epub 2011 Aug 24.
- Derived from this study: PubMed 25098701Odia Y, Shih JH, Kreisl TN, Fine HA. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014 Nov;120(2):431-40. doi: 10.1007/s11060-014-1571-6. Epub 2014 Aug 7.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Common Terminology Criteria for Adverse Events (CTCAE)v3.0Link provided by the sponsor.
- Response criteria for malignant gliomasLink provided by the sponsor.
- Criteria for malignant brain tumorsLink provided by the sponsor.
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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.
Teri Kreisl, M.D. principal investigator
National Cancer Institute, National Institutes of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Recurrent High-Grade Gliomas and Malignant Gliomas, run by National Cancer Institute (NCI) 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 54 inclusion and 37 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 29 Apr 2014. 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 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?
Yes. Results are posted in the registry (first posted 8 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Percentage of Participants With Progression Free Survival at 6 Months. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271609, which also lists 5 linked publications.
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 29 Apr 2014.