Neoplastic MeningitisPhase 1/2NCT00924820
A Pilot Study of Bevacizumab for Neoplastic Meningitis
A Phase 1/2 study testing Bevacizumab in people with Neoplastic Meningitis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of this drug will also be studied. Objectives: 1. Primary: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplastic Meningitis
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 2015
- Phase
- Phase 1/2
- 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
- History of breast cancer, lung cancer or melanoma
- Diagnosis of NM as proven either by: 1. positive CSF cytology, or 2. magnetic resonance neuro-imaging, or 3. both
- Age >/=18 years.
- Routine laboratory studies adequate with bilirubin </= 1.5 x upper limit of normal (ULN), AST < 2.5 x ULN, creatinine <1.0 x ULN, granulocytes >1500, platelets> 75,000; Hb >/= 9.0.
- Patient able to sign informed consent and willing to participate in study primary objectives
- At least 1 week from last intrathecal chemotherapy (>2 weeks if liposomal cytarabine). Patients are allowed to have received prior chemotherapy for their tumor. No limit on prior chemotherapies will be made. Patients who have been treated with tyrosine kinase inhibitors are permitted. Prior anti-VEGF targeted therapy is not permitted, unless patient has been off anti-VEGF therapy for 6 months and did not develop NM while on anti-VEGF therapy
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- Karnofsky performance status (KPS) >/= 50%
- Pre-treatment CSF Indium 111 CSF flow study without evidence of obstruction.
- Patients on full-dose anticoagulants (e.g., warfarin) with PT international normalized ratio (INR) >1.5 are eligible provided that: 1. Patients are receiving anticoagulation (warfarin or low molecular weight heparins (LMWH)) only if the patients can be off of warfarin for 4-5 days prior to the LP and placed on LMWH in that interim, and if the 'treatment dose' of LMWH can be safely held for 24 hours before and after the LP.
- ( 9. continued) INR must be <1.2 prior to LP in this circumstance. If patients are receiving thromboprophylaxis dose of LMWH, the patients can be enrolled, but the thromboprophylaxis LMWH must be able to be safely held for 12 hours prior to the LP. 2. The patient has no active bleeding or pathological condition that carries a high risk of bleeding 3. There is no evidence of serious or non-healing wound, ulcer or bone fracture
- Ventricular reservoir NOT mandatory
Who cannot join
- Evidence of active CNS hemorrhage in the brain or tumor lesions
- Besides NM, other known CNS disease, except for treated brain metastases(Patients must be at least 1 month out from brain irradiation and have no evidence of progression or hemorrhage at that time, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period). Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery or a combination as deemed appropriate by the treating physician.
- (2. continued) With respect to irradiation for other purpose (for NM or bone metastases, etc) patients need only 1 week out from the completion of irradiation. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- Patients with clinically significant cardiovascular disease are excluded 1) Inadequately controlled HTN (SBP > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg despite antihypertensive medication). 2) Prior history of hypertensive crisis or hypertensive encephalopathy. 3) New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- ( 4. Continued) 4) History of myocardial infarction or unstable angina within 6 months prior to Day 1. 5) History of stroke or transient ischemic attack within 6 months prior to Day 1. 6) Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1. 7) Clinically significant peripheral vascular disease. 8) Serious and inadequately controlled cardiac arrhythmia
- History of hemoptysis (>/= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
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- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1. Ventricular reservoir must have been placed more than 28 days prior to Day 1.
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by UPC ratio >/=1.0 at screening or by urine dipstick >/= 2+. (Patients discovered to have >/= 2+ proteinuria on urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible).
- Known hypersensitivity to any component of bevacizumab
- Intrathoracic or extrathoracic lung carcinoma of squamous cell histology. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is acceptable.
- (14. continued) Patients with extrathoracic-only squamous cell NSCLC are eligible. Patients with only peripheral lung lesions (of any non squamous NSCLC histology, except small cell histology) will also be eligible (a peripheral lesion is defined as a lesion in which the epicenter of the tumor is </= 2 cm from the costal or diaphragmatic pleura in a three-dimensional orientation based on each lobe of the lung and is >/= 2 cm from the trachea, main, and lobar bronchi).
- Pregnant (positive pregnancy test) or nursing women. Angiogenesis is critical to fetal development and the inhibition of angiogenesis following administration of AVASTIN is likely to result in adverse effects on pregnancy. There are no adequate and well-controlled studies in pregnant women. Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 2 months after the completion of bevacizumab therapy.
- General Medical Exclusions 1) Inability to comply with study and/or follow-up procedures 2) Life expectancy of less than 6 weeks 3) Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this Genentech supported study 4) Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of this drug will also be studied.
Objectives:
- Primary:
- Determine preliminary response data of intravenous bevacizumab in patients with NM
- As measured by clearance of malignant cells from the Cerebrospinal fluid (CSF) at 2, 4, 6, 12, 18, and 24 weeks, then every 8 weeks up to 54 weeks, and
- Time to neurological progression (TTNP)
- Secondary:
- Evaluate the safety of intravenous bevacizumab in patients with NM
- Further describe the efficacy of this intervention as measured by
- improvement of MR imaging evidence of disease
- overall survival
- maintenance of quality of life
- Determine effects of systemically administered bevacizumab on CSF, serum, and urine Vascular endothelial growth factor (VEGF)levels levels
- Correlate changes in CSF VEGF with response measurements.
- Correlate primary tumor tissue VEGF expression with CSF VEGF levels
- Correlate urine VEGF levels with serum and CSF VEGF levels
- Evaluate serum and CSF VEGF index
Read the detailed description
The Study Drug:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Study Drug Administration:
If you are found to be eligible to take part in this study, every 2 weeks, you will receive bevacizumab by vein over about 1 hour.
Study Visits:
At Weeks 2 and 4:
- Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
- If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
- You will be asked about any drugs you may be taking and if you have experienced any side effects.
- You will have a neurological exam.
At Weeks 6, 12, 18, and 24, and then every 8 weeks:
- Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
- If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
- You will have a physical exam (Weeks .
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and if you have experienced any side effects.
- You will have a neurological exam.
- You will complete the questionnaire about your quality of life.
- You will have an MRI scan to check the status of the disease.
- Urine will be collected to test kidney function and for routine tests. If indicated urine will be collected over a 24 hour period.
Every 2 weeks, your blood pressure will be measured.
Length of Study:
You will be on study for up to 54 weeks (about 1 year). You will be taken off study early if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
If you go off study early, the following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- You will have a neurological exam.
- Samples of CSF from your spinal cord will be collected to look for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. You will complete the questionnaire about your quality of life.
- If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
Follow-up Visits:
If you do not go off study early, within 4 weeks after the last dose of study drug, every 4 weeks for 3 months, and then every 3 months from then on, you will have follow-up visits. The following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- You will have a neurological exam.
- Samples of CSF from your spinal will be collected to look for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
You will have an MRI scan to check the status of the disease.
-If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, breast, and lung cancer. Its use for the treatment of cancer that has spread to the meninges of the brain or the spinal cord is investigational.
Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Neoplastic Meningitis
- Being tested
- Bevacizumab
- Keywords
- Neoplastic Meningitis, NM, Advanced Cancers, Brain Cancer, Advanced Cancer, Brain Diseases, Central Nervous System Disorders, CNS, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Spinal Cord, meninges, cerebrospinal fluid, CSF
- Medical subject headings
- Meningeal Carcinomatosis, Brain Neoplasms, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
10 mg/kg by vein over about 1 hour, every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells
CSF response for participants with Neoplastic Meningitis (NM) or leptomeningeal disease (LMD) defined as conversion from positive to negative cytology or cytometry as measured routinely by total clearance of malignant cells from the CSF where assessments performed from 2 weeks up to week 54 of treatment. Clearance of malignant cells determined by standard clinical testing using cytospin analysis in clinical laboratory. Percentage reflects number of participants of total treated with no response, e.g. participants with continued positive CSF cytology or flow cytometry.
Measured: 1 year (54 weeks) of treatment
Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP)
Time to Progression defined as time to disease progression measured from date of enrollment, confirmation of disease progression via laboratory testing; Time to neurological progression (TTNP) reflects worsening clinical signs/symptoms or development of new clinical signs/symptoms which investigator feels can be attributed to leptomeningeal disease progression and are severe enough to warrant a change in therapy.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2015
- Study completionSep 2015
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.
- Other trials for Neoplastic MeningitisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Ivo D. Tremont, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924820
- Sponsor's protocol ID
- 2009-0122
- Other IDs
- NCI-2009-01610
- Status last verified
- Dec 2020
- First submitted
- 18 Jun 2009
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
- ClinicalTrials.gov ID
- NCT00924820
- Acronym / sponsor ID
- 2009-0122
- Conditions
- Neoplastic Meningitis
- Keywords
- Neoplastic Meningitis, NM, Advanced Cancers, Brain Cancer, Advanced Cancer, Brain Diseases, Central Nervous System Disorders, CNS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of this drug will also be studied.
Objectives:
- Primary:
- Determine preliminary response data of intravenous bevacizumab in patients with NM
- As measured by clearance of malignant cells from the Cerebrospinal fluid (CSF) at 2, 4, 6, 12, 18, and 24 weeks, then every 8 weeks up to 54 weeks, and
- Time to neurological progression (TTNP)
- Secondary:
- Evaluate the safety of intravenous bevacizumab in patients with NM
- Further describe the efficacy of this intervention as measured by
- improvement of MR imaging evidence of disease
- overall survival
- maintenance of quality of life
- Determine effects of systemically administered bevacizumab on CSF, serum, and urine Vascular endothelial growth factor (VEGF)levels levels
- Correlate changes in CSF VEGF with response measurements.
- Correlate primary tumor tissue VEGF expression with CSF VEGF levels
- Correlate urine VEGF levels with serum and CSF VEGF levels
- Evaluate serum and CSF VEGF index
Detailed description
The Study Drug:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Study Drug Administration:
If you are found to be eligible to take part in this study, every 2 weeks, you will receive bevacizumab by vein over about 1 hour.
Study Visits:
At Weeks 2 and 4:
- Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
- If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
- You will be asked about any drugs you may be taking and if you have experienced any side effects.
- You will have a neurological exam.
At Weeks 6, 12, 18, and 24, and then every 8 weeks:
- Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
- If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
- You will have a physical exam (Weeks .
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and if you have experienced any side effects.
- You will have a neurological exam.
- You will complete the questionnaire about your quality of life.
- You will have an MRI scan to check the status of the disease.
- Urine will be collected to test kidney function and for routine tests. If indicated urine will be collected over a 24 hour period.
Every 2 weeks, your blood pressure will be measured.
Length of Study:
You will be on study for up to 54 weeks (about 1 year). You will be taken off study early if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
If you go off study early, the following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- You will have a neurological exam.
- Samples of CSF from your spinal cord will be collected to look for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. You will complete the questionnaire about your quality of life.
- If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
Follow-up Visits:
If you do not go off study early, within 4 weeks after the last dose of study drug, every 4 weeks for 3 months, and then every 3 months from then on, you will have follow-up visits. The following tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- You will have a neurological exam.
- Samples of CSF from your spinal will be collected to look for the presence of cancer cells.
- Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally.
You will have an MRI scan to check the status of the disease.
-If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells.
This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, breast, and lung cancer. Its use for the treatment of cancer that has spread to the meninges of the brain or the spinal cord is investigational.
Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabBevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- History of breast cancer, lung cancer or melanoma
- Diagnosis of NM as proven either by: 1. positive CSF cytology, or 2. magnetic resonance neuro-imaging, or 3. both
- Age >/=18 years.
- Routine laboratory studies adequate with bilirubin </= 1.5 x upper limit of normal (ULN), AST < 2.5 x ULN, creatinine <1.0 x ULN, granulocytes >1500, platelets> 75,000; Hb >/= 9.0.
- Patient able to sign informed consent and willing to participate in study primary objectives
Key exclusion criteria (17 listed)
- Evidence of active CNS hemorrhage in the brain or tumor lesions
- Besides NM, other known CNS disease, except for treated brain metastases(Patients must be at least 1 month out from brain irradiation and have no evidence of progression or hemorrhage at that time, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period). Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery or a combination as deemed appropriate by the treating physician.
- (2. continued) With respect to irradiation for other purpose (for NM or bone metastases, etc) patients need only 1 week out from the completion of irradiation. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
- Patients with clinically significant cardiovascular disease are excluded 1) Inadequately controlled HTN (SBP > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg despite antihypertensive medication). 2) Prior history of hypertensive crisis or hypertensive encephalopathy. 3) New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- ( 4. Continued) 4) History of myocardial infarction or unstable angina within 6 months prior to Day 1. 5) History of stroke or transient ischemic attack within 6 months prior to Day 1. 6) Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1. 7) Clinically significant peripheral vascular disease. 8) Serious and inadequately controlled cardiac arrhythmia
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: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF10 mg/kg by vein over about 1 hour, every 2 weeks. | Drug | Bevacizumab |
Primary outcome
Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells
Time frame: 1 year (54 weeks) of treatment
CSF response for participants with Neoplastic Meningitis (NM) or leptomeningeal disease (LMD) defined as conversion from positive to negative cytology or cytometry as measured routinely by total clearance of malignant cells from the CSF where assessments performed from 2 weeks up to week 54 of treatment. Clearance of malignant cells determined by standard clinical testing using cytospin analysis in clinical laboratory. Percentage reflects number of participants of total treated with no response, e.g. participants with continued positive CSF cytology or flow cytometry.
Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP)
Time frame: 6 weeks
Time to Progression defined as time to disease progression measured from date of enrollment, confirmation of disease progression via laboratory testing; Time to neurological progression (TTNP) reflects worsening clinical signs/symptoms or development of new clinical signs/symptoms which investigator feels can be attributed to leptomeningeal disease progression and are severe enough to warrant a change in therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Ivo D. Tremont, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab in people with Neoplastic Meningitis, run by M.D. Anderson Cancer Center 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 11 inclusion and 17 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 31 Dec 2020. 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 combined 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.
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 31 Dec 2020). 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?
Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells (time frame: 1 year (54 weeks) of treatment). 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?
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 31 Dec 2020.