Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study
This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01737671
First received: November 27, 2012
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
The goal of this clinical research study is to learn if methotrexate infused into the fourth ventricle of the brain can help to control brain tumors. The safety of this drug will also be studied.
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.
| Condition | Intervention |
|---|---|
|
Brain Tumor Malignant Neoplasm of Fourth Ventricle of Brain |
Procedure: Ommaya Reservoir Drug: Methotrexate Drug: Leucovorin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Neurological Deficits After Administration of Methotrexate into the Fourth Ventricle of the Brain [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Methotrexate Infusion
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. Leucovorin 5 mg/square meter per dose administered after each cycle of intraventricular methotrexate.
|
Procedure: Ommaya Reservoir
Surgical catheter placement into the fourth ventricle of the brain.
Drug: Methotrexate
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.
Drug: Leucovorin
5 mg/square meter per dose administered after each cycle of intraventricular methotrexate. Two intravenous doses administered in total after each cycle. The first leucovorin dose administered 24 hours after the last intraventricular methotrexate dose of each cycle and the second leucovorin dose administered 36 hours after the last intraventricular methotrexate dose of each cycle.
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | up to 22 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients under the age of 22 years with recurrent ependymoma involving the brain and/or spine, or recurrent ependymoma involving the brain and/or spine, or recurrent atypical teratoid/rhabdoid tumor (AT/RT) involving the brain and/or spine.
- Patients must have a life expectancy of at least 12 weeks as estimated by the treating oncologist and/or neurosurgeon to be considered for enrollment. Patients must have a Lansky Performance status of at least 20 to be eligible for enrollment.
- Female patients who are post-menarchal must have a negative pregnancy test to be eligible.
- 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
- Prior to receiving intraventricular methotrexate, patients must have adequate bone marrow function, defined as: Peripheral absolute neutrophil count (ANC) >/= 1000/µL, Platelet count = 30,000/µL (transfusion independent), Hemoglobin = 9.0 gm/dL (may receive red blood cell (RBC) transfusions)
- All patients and/or their parents or legal guardians must sign a written informed consent.
Exclusion Criteria:
- Patients will be excluded from this study if a shunt has been placed for treatment of hydrocephalus. If the shunt is subsequently removed or ligated, then the patient will no longer be excluded from eligibility.
- Patients will be excluded from this study if currently enrolled in another experimental treatment protocol or if receiving any other chemotherapy (either systemic or intrathecal).
- Pregnant or lactating female patients are ineligible
- Patients will be excluded from this study if they have received another investigational or chemotherapy agent within 14 days prior to study entry.
- Patients will be excluded from this study if they have any evidence of infection in any site at the time of considered enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737671
Contacts
| Contact: Soumen Khatua, MD | 713-792-6610 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Children's Memorial Hermann Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Soumen Khatua, MD | UT MD Anderson Cancer Center |
| Principal Investigator: | David Sandberg, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01737671 History of Changes |
| Other Study ID Numbers: | 2012-0823 |
| Study First Received: | November 27, 2012 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Brain tumor Malignant Fourth Ventricular Brain Tumors Ependymoma involving brain Recurrent ependymoma involving brain and/or spine Recurrent atypical teratoid/rhabdoid tumor involving brain Recurrent atypical teratoid/rhabdoid tumor involving spine Atypical teratoid rhabdoid tumor Pediatric brain tumor |
Ependymoma involving spine AT/RT Ommaya reservoir catheter Methotrexate Medulloblastoma ATRT Ependymoma Intraventricular chemotherapy |
Additional relevant MeSH terms:
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Brain Neoplasms Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Leucovorin Levoleucovorin Methotrexate Vitamin B Complex Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013