Iris C. Gibbs, MD
Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy. PURPOSE: This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: memantine hydrochloride
- Drug: placebo
- Procedure: radiation therapy
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years
o If the original histologic proof of malignancy is > 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
* Brain metastases must be visible on contrast-enhanced MRI or a contrast enhanced CT scan (for patients unable to undergo MRI within the past 28 days)
o Patients unable to undergo MRI imaging because of non-compatible devices are eligible, provided the contrast-enhanced CT scans are obtained and are of sufficient quality
o Patients who had undergone radiosurgery or surgical resection and are planning adjuvant whole-brain radiotherapy do not have to have visible disease but do need a baseline MRI
* Must have stable systemic disease (i.e. no evidence of systemic disease progression within the past 3 months)
* Patients with brain metastases at initial presentation are eligible and do not need to demonstrate 3 months of stable scans
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Serum creatinine <= 3 mg/dL and creatinine clearance >= 30 mL/min
* Total bilirubin <= 2.5 mg/dL
* BUN < 20 mg/dL
* Mini-mental status exam score >= 18
* Negative serum pregnancy test
* Fertile patients must practice adequate contraception
PRIOR CONCURRENT THERAPY:
* At least 14 days but no more than 56 days since prior therapy for brain metastasis, including radiosurgery and surgical resection
* No systemic chemotherapy for 14 days prior, during, or for 14 days after completion of whole-brain radiotherapy (WBRT)
Key Exclusion Criteria:
PATIENT CHARACTERISTICS:
* Severe, active co-morbidity, defined as follows:
o Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
o Transmural myocardial infarction within the last 6 months
o Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
o Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
o Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Pregnant or lactating women
* Prior allergic reaction to memantine hydrochloride
* Current alcohol or drug abuse
* Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)
PRIOR CONCURRENT THERAPY:
* Prior cranial radiotherapy
o Patients may have received up to 3 prior WBRT treatments and still be registered and randomized on the protocol provided WBRT parameters meet protocol requirements
* Chronic short-acting benzodiazepine use
Additional Study Details
Official Title:
A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain RadiotherapyAnticipated start date:
4/28/2009Lead Sponsor:
Radiation Therapy Oncology GroupCollaborator(s):
- National Cancer Institute (NCI)
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Cognitive function, specifically memory, 24 weeks from the start of drug treatment as measured by the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-delayed recall) [ Designated as safety issue: No ]
Secondary Outcomes:
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Adverse events based on CTCAE 3.0 [ Designated as safety issue: Yes ]
- Collection of serum, plasma, buffy coat cells, urine, and cerebrospinal fluid for future translational research analyses [ Designated as safety issue: No ]
- Cognitive function, specifically memory, 8 weeks, 16 weeks, and 12 months from the start of treatment as measured by the HVLT-R-delayed recall [ Designated as safety issue: No ]
- Neurocognitive failure as measured by a battery of tests [ Designated as safety issue: No ]
- Quality-of-life as measured by the Functional Assessment of Cancer Therapy Brain subscale (FACT-Br) [ Designated as safety issue: No ]
Total Number to be Enrolled:
536Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- CDR0000577872
- NCT00566852
- RTOG-0614
- RTOG0614
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/8/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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