Brain TumorEarly Phase 1NCT01737671
Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study
A Early Phase 1 study testing Ommaya Reservoir, Methotrexate and Leucovorin in people with Brain Tumor and Malignant Neoplasm of Fourth Ventricle of Brain, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to learn if it is safe to receive methotrexate through the fourth ventricle of the brain in patients with brain tumors. Methotrexate is designed to block cancer cells from dividing, which may slow or stop their growth and spread throughout the body. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Brain Tumor, Malignant Neoplasm of Fourth Ventricle of Brain
- What is being tested?
- Ommaya Reservoir, Methotrexate and Leucovorin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Dec 2012to 11 Jan 2018
- Phase
- Early 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 Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- There will be a two-step process of eligibility assessment: Step 1: Eligibility for catheter placement and possible surgical removal of tumor. Step 2: Eligibility for methotrexate infusion.
- Step 1 Eligibility (Pre-Operative Eligibility) Includes: Diagnosis and Age - Patients with tumor originally located within the posterior fossa of the brain: *Patients ≤ age 21 years with recurrent medulloblastoma (PNET) involving the brain and/or spine *Patients ≤ age 21 years with recurrent ependymoma involving the brain and/or spine *Patients ≤ age 21 years with recurrent atypical teratoid/rhabdoid tumor (AT/RT) involving the brain and/or spine.
- Step 1 Elig.: Life Expectancy - Patients must have a life expectancy of at least 12 weeks as estimated by the treating oncologist and neurosurgeon to be considered for enrollment.
- Step 1 Elig: Central Nervous System Function - Patients may be enrolled in the study if they have an altered neurological status, such as somnolence, which is attributed to hydrocephalus and/or mass effect from the brain tumor by the treating physicians. However, after tumor resection and placement of the catheter into the fourth ventricle, the protocol will only be continued if the patient has adequate central nervous system function, defined as: patient is not severely somnolent or comatose and has adequate clinical performance status as defined in protocol section 3.2.2.1.
- Step 2 Elig. (MTX Infusion Elig.): Clinical Performance Status - Patients must have a Lansky score of 50 or greater if ≤ 16 years of age and a Karnofsky score of 50 or greater if they are > 16 years of age to be eligible for enrollment (See Protocol Section 14.1 for Lansky Play-Performance Scale information; See Protocol Section 14.2 for Karnofsky Performance Scale information).
- Step 2 Elig: Pregnancy - Female patients who are post-menarchal must have a negative pregnancy test to be eligible. Pregnant or lactating female patients are ineligible.
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- Step 2 Elig: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. a. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study. b. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with a growth factor. c. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. These patients must be discussed with the study chair on a case by case basis.
- Step 2 Elig: Bone Marrow Function - patients must have adequate bone marrow function, defined as: a. Peripheral absolute neutrophil count (ANC) ≥ 1000/µL b. Platelet count ≥ 30,000/µL (transfusion independent) c. Hemoglobin ≥ 9.0 gm/dL (may receive RBC transfusions) d. Post-op CSF flow study shows re-establishment of CSF flow.
- All patients and/or their parents or legal guardians must sign a written informed consent.
Who cannot join
- Patients will be excluded from this study if currently enrolled in another experimental treatment protocol.
- Patients will be excluded from this study if they have any evidence of infection, in any site, at the time of considered enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Memorial Hermann Hospital
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if it is safe to receive methotrexate through the fourth ventricle of the brain in patients with brain tumors.
Methotrexate is designed to block cancer cells from dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Read the detailed description
Catheter Placement:
If you are eligible to take part in this study, you will have surgery to place a catheter into the ommaya reservoir. The ommaya reservoir is a catheter system that allows drugs to be administered directly to parts of the brain. In this study, the catheter will be used to collect about 1 teaspoon of cerebrospinal fluid (CSF - the fluid surrounding the brain and spinal cord) to check the status of the disease and for the infusion of methotrexate directly into the 4th ventricle of the brain, which is 1 of the 4 connected fluid-filled cavities in the brain.
If the study doctor thinks it is necessary, based on the location of the tumor, the tumor may also be removed while you are already under anesthesia just before the catheter is placed.
Study Drug Administration:
Each cycle is 4 days long and will consist of 4 daily infusions of methotrexate. You will have at least a 2 week rest period between each cycle.
Methotrexate will be infused through the ommaya reservoir catheter directly into the 4th ventricle of the brain starting at least 7 days after the catheter placement surgery. The infusion should last about 3 minutes each time.
You may also be given leucovorin, a drug used to help prevent or treat the side effects of methotrexate, by intravenous (IV) infusion through a catheter or port you have already had placed in your arm. If the study doctor thinks it is needed, this infusion will be given after each cycle to help with the possible side effects you may experience from methotrexate. The infusion should last about 5 minutes each time.
Study Visits:
Within 72 hours after catheter placement surgery:
- Any updates to your health will be recorded.
- You will have an MRI scan of the brain and spine to check the status of the disease and the flow of brain fluid.
Within seven (7) days after catheter placement surgery:
- Any updates to your health will be recorded.
- You will have a neurological exam.
- You will have a spinal tap (also called a lumbar puncture). A lumbar puncture is a procedure where fluid surrounding the spinal cord is removed by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure.
- You will have a neuropsychological test performed by a neuropsychologist. For this test, you will be asked questions that will test your memory and brain function. The test should take about 3 hours.
On Day 1 of each methotrexate infusion for Cycles 1-3:
- You will have a neurological exam.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If you are able to become pregnant, you will have a urine pregnancy test.
Daily during each methotrexate infusion for Cycles 1-3:
- You will have a neurological exam.
- You will have an Ommaya reservoir tap (a catheter is placed into the Ommaya reservoir to give the methotrexate infusion).
- CSF (about 1 teaspoon) will be collected for routine tests. Blood (about 1 teaspoon each time) will be drawn to learn how much methotrexate is in your blood.
After you have completed Cycle 3:
You will have an MRI scan of the brain and spine to check the status of the disease and the flow of brain fluid.
You will have a spinal tap. You will have a neuropsychological test performed by a neuropsychologist. For this test, you will be asked questions that will test your memory and brain function. The test should take about 3 hours.
If the study doctor thinks it is in your best interest, you will continue with additional cycles of methotrexate therapy, with required tests and procedures. Your doctor may recommend additional surgery. Your doctor will discuss this with you.
Also, if the study doctor thinks it is in your best interest, methotrexate may be given together with other chemotherapy after completion of Cycle 3. If you will be receiving other chemotherapy, the study doctor will speak with you in more detail about what drugs you will receive and how you will receive them.
Length of Study:
You will receive up to 3 cycles of the methotrexate, or as long as the doctor thinks it is your best interest. You will no longer be able to receive the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after you complete the follow-up visits.
Follow-Up Visit:
3 months after the final dose of study drug:
- Any updates to your health will be recorded.
- You will have a neurological exam.
- You will have an MRI scan of the brain and spine to check the status of the disease.
This is an investigational study. Methotrexate is FDA approved and commercially available for infusion directly into brain tumors. The infusion of methotrexate into the 4th ventricle of the brain is investigational.
Up to 12 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Being tested
- Ommaya Reservoir, Methotrexate, Leucovorin
- Keywords
- Brain tumor, Malignant Fourth Ventricular Brain Tumors, Ependymoma involving brain, Ependymoma involving spine, Recurrent ependymoma involving brain and/or spine, Recurrent atypical teratoid/rhabdoid tumor involving brain, Recurrent atypical teratoid/rhabdoid tumor involving spine, AT/RT, Ommaya reservoir catheter, Methotrexate, Medulloblastoma, ATRT, Atypical teratoid rhabdoid tumor, Ependymoma, Pediatric brain tumor, Intraventricular chemotherapy
- Medical subject headings
- Brain Neoplasms, Medulloblastoma, Rhabdoid Tumor, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ommaya ReservoirProcedure or surgery
Surgical catheter placement into the fourth ventricle of the brain.
MethotrexateDrug
2 mg into fourth ventricle of the brain via the Ommaya Reservoir for 4 days. Each patient will undergo three cycles with at least two weeks between each cycle.
LeucovorinDrug
Also called Citrovorum, Wellcovorin
5 mg/square meter per dose administered every 6 hours by vein or mouth.
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate Infusion | Experimental | 3 consecutive cycles of intraventricular methotrexate infusions into implanted fourth ventricle catheter/Ommaya reservoir following surgical catheter placement into fourth ventricle, each cycle is 4 consecutive daily doses of intraventricular methotrexate with minimum 2 weeks between cycles. If any serum methotrexate level is > 0.3 micromolar, then Leucovorin therapy administered (5 mg/square meter per dose) every 6 hours by vein or mouth. Receives: Procedure: Ommaya Reservoir; Drug: Methotrexate; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Deficits After Administration of Methotrexate into the Fourth Ventricle of the Brain
New neurological deficit defined as new cranial neuropathy, nystagmus, change in mental status, motor deficit, or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to intraventricular methotrexate infusions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study start27 Dec 2012
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soumen Khatua, MD, Study chair, M.D. Anderson Cancer CenterDavid Sandberg, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737671
- Sponsor's protocol ID
- 2012-0823
- Other IDs
- NCI-2013-00045
- Status last verified
- Jan 2018
- First submitted
- 27 Nov 2012
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study
- ClinicalTrials.gov ID
- NCT01737671
- Acronym / sponsor ID
- 2012-0823
- Keywords
- Brain tumor, Malignant Fourth Ventricular Brain Tumors, Ependymoma involving brain, Ependymoma involving spine, Recurrent ependymoma involving brain and/or spine, Recurrent atypical teratoid/rhabdoid tumor involving brain, Recurrent atypical teratoid/rhabdoid tumor involving spine, AT/RT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 Dec 2012 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 29 Nov 2012 (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.
The goal of this clinical research study is to learn if it is safe to receive methotrexate through the fourth ventricle of the brain in patients with brain tumors.
Methotrexate is designed to block cancer cells from dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Detailed description
Catheter Placement:
If you are eligible to take part in this study, you will have surgery to place a catheter into the ommaya reservoir. The ommaya reservoir is a catheter system that allows drugs to be administered directly to parts of the brain. In this study, the catheter will be used to collect about 1 teaspoon of cerebrospinal fluid (CSF - the fluid surrounding the brain and spinal cord) to check the status of the disease and for the infusion of methotrexate directly into the 4th ventricle of the brain, which is 1 of the 4 connected fluid-filled cavities in the brain.
If the study doctor thinks it is necessary, based on the location of the tumor, the tumor may also be removed while you are already under anesthesia just before the catheter is placed.
Study Drug Administration:
Each cycle is 4 days long and will consist of 4 daily infusions of methotrexate. You will have at least a 2 week rest period between each cycle.
Methotrexate will be infused through the ommaya reservoir catheter directly into the 4th ventricle of the brain starting at least 7 days after the catheter placement surgery. The infusion should last about 3 minutes each time.
You may also be given leucovorin, a drug used to help prevent or treat the side effects of methotrexate, by intravenous (IV) infusion through a catheter or port you have already had placed in your arm. If the study doctor thinks it is needed, this infusion will be given after each cycle to help with the possible side effects you may experience from methotrexate. The infusion should last about 5 minutes each time.
Study Visits:
Within 72 hours after catheter placement surgery:
- Any updates to your health will be recorded.
- You will have an MRI scan of the brain and spine to check the status of the disease and the flow of brain fluid.
Within seven (7) days after catheter placement surgery:
- Any updates to your health will be recorded.
- You will have a neurological exam.
- You will have a spinal tap (also called a lumbar puncture). A lumbar puncture is a procedure where fluid surrounding the spinal cord is removed by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure.
- You will have a neuropsychological test performed by a neuropsychologist. For this test, you will be asked questions that will test your memory and brain function. The test should take about 3 hours.
On Day 1 of each methotrexate infusion for Cycles 1-3:
- You will have a neurological exam.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If you are able to become pregnant, you will have a urine pregnancy test.
Daily during each methotrexate infusion for Cycles 1-3:
- You will have a neurological exam.
- You will have an Ommaya reservoir tap (a catheter is placed into the Ommaya reservoir to give the methotrexate infusion).
- CSF (about 1 teaspoon) will be collected for routine tests. Blood (about 1 teaspoon each time) will be drawn to learn how much methotrexate is in your blood.
After you have completed Cycle 3:
You will have an MRI scan of the brain and spine to check the status of the disease and the flow of brain fluid.
You will have a spinal tap. You will have a neuropsychological test performed by a neuropsychologist. For this test, you will be asked questions that will test your memory and brain function. The test should take about 3 hours.
If the study doctor thinks it is in your best interest, you will continue with additional cycles of methotrexate therapy, with required tests and procedures. Your doctor may recommend additional surgery. Your doctor will discuss this with you.
Also, if the study doctor thinks it is in your best interest, methotrexate may be given together with other chemotherapy after completion of Cycle 3. If you will be receiving other chemotherapy, the study doctor will speak with you in more detail about what drugs you will receive and how you will receive them.
Length of Study:
You will receive up to 3 cycles of the methotrexate, or as long as the doctor thinks it is your best interest. You will no longer be able to receive the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after you complete the follow-up visits.
Follow-Up Visit:
3 months after the final dose of study drug:
- Any updates to your health will be recorded.
- You will have a neurological exam.
- You will have an MRI scan of the brain and spine to check the status of the disease.
This is an investigational study. Methotrexate is FDA approved and commercially available for infusion directly into brain tumors. The infusion of methotrexate into the 4th ventricle of the brain is investigational.
Up to 12 patients will be enrolled 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 |
|---|---|---|
| Methotrexate Infusion | Experimental | Procedure: Ommaya Reservoir, Drug: Methotrexate, Drug: Leucovorin3 consecutive cycles of intraventricular methotrexate infusions into implanted fourth ventricle catheter/Ommaya reservoir following surgical catheter placement into fourth ventricle, each cycle is 4 consecutive daily doses of intraventricular methotrexate with minimum 2 weeks between cycles. If any serum methotrexate level is > 0.3 micromolar, then Leucovorin therapy administered (5 mg/square meter per dose) every 6 hours by vein or mouth. |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- There will be a two-step process of eligibility assessment: Step 1: Eligibility for catheter placement and possible surgical removal of tumor. Step 2: Eligibility for methotrexate infusion.
- Step 1 Eligibility (Pre-Operative Eligibility) Includes: Diagnosis and Age - Patients with tumor originally located within the posterior fossa of the brain: *Patients ≤ age 21 years with recurrent medulloblastoma (PNET) involving the brain and/or spine *Patients ≤ age 21 years with recurrent ependymoma involving the brain and/or spine *Patients ≤ age 21 years with recurrent atypical teratoid/rhabdoid tumor (AT/RT) involving the brain and/or spine.
- Step 1 Elig.: Life Expectancy - Patients must have a life expectancy of at least 12 weeks as estimated by the treating oncologist and neurosurgeon to be considered for enrollment.
- Step 1 Elig: Central Nervous System Function - Patients may be enrolled in the study if they have an altered neurological status, such as somnolence, which is attributed to hydrocephalus and/or mass effect from the brain tumor by the treating physicians. However, after tumor resection and placement of the catheter into the fourth ventricle, the protocol will only be continued if the patient has adequate central nervous system function, defined as: patient is not severely somnolent or comatose and has adequate clinical performance status as defined in protocol section 3.2.2.1.
- Step 2 Elig. (MTX Infusion Elig.): Clinical Performance Status - Patients must have a Lansky score of 50 or greater if ≤ 16 years of age and a Karnofsky score of 50 or greater if they are > 16 years of age to be eligible for enrollment (See Protocol Section 14.1 for Lansky Play-Performance Scale information; See Protocol Section 14.2 for Karnofsky Performance Scale information).
Key exclusion criteria (2 listed)
- Patients will be excluded from this study if currently enrolled in another experimental treatment protocol.
- Patients will be excluded from this study if they have any evidence of infection, in any site, at the time of considered enrollment.
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 |
|---|---|---|
| Ommaya ReservoirSurgical catheter placement into the fourth ventricle of the brain. | Procedure or surgery | Methotrexate Infusion |
| Methotrexate2 mg into fourth ventricle of the brain via the Ommaya Reservoir for 4 days. Each patient will undergo three cycles with at least two weeks between each cycle. | Drug | Methotrexate Infusion |
| LeucovorinAlso: Citrovorum, Wellcovorin5 mg/square meter per dose administered every 6 hours by vein or mouth. | Drug | Methotrexate Infusion |
Primary outcome
Neurological Deficits After Administration of Methotrexate into the Fourth Ventricle of the Brain
Time frame: 3 months
New neurological deficit defined as new cranial neuropathy, nystagmus, change in mental status, motor deficit, or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to intraventricular methotrexate infusions.
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 19 Jan 2018.
- 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.
Soumen Khatua, MD study chair
M.D. Anderson Cancer Center
David Sandberg, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ommaya Reservoir, Methotrexate and Leucovorin in people with Brain Tumor and Malignant Neoplasm of Fourth Ventricle of Brain, run by M.D. Anderson Cancer Center at 2 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 9 inclusion and 2 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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.
What does the primary outcome measure?
Neurological Deficits After Administration of Methotrexate into the Fourth Ventricle of the Brain (time frame: 3 months). 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 19 Jan 2018.