Upstate Active Clinical Trials Seeking Participants
Study title
A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy
IRB number
5849
What is the purpose of the study?
To determine whether the addition of memantine to whole brain radiation therapy preserves cognitive function, specifically memory as measured by battery of verbal tests for recall, recognition, and neurocognitive assessment
Who is eligible?
1)Pathologically histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e. more recent) confirmation is required (e.g. from a systemic metastasis or brain metastasis).
2)Brain metastases must be visible on contrast enhanced MRI or a contrast enhanced CT for patients unable to have an MRI performed no more than 28 days prior to study entry (an allowed exception, regarding ability to image brain metastases, would be patients who had undergone radiosurgery or surgical resection and are planning adjuvant WBRT do not have to have visible disease but do need a baseline MRI). Patients unable to undergo MR imaging because of non compatible devices can be enrolled, provided the contrast enhanced CT scans are obtained and are of sufficient quality.
3)Patients must have stable systemic disease (i.e. no evidence of systemic disease progression 3 months prior to study entry). Patients who have brain metastases at initial presenation are eligible and do not need to demonstrate 3 months of stable scans.
4) Karnofsky Performance Status of 70 or greater within 28 days prior to study entry.
5) Age 18 or older
6) Serum creatinine and total bilirubin obtained 28 days prior to study entry; with adequate kidney and liver function.
7) BUN greater than 20 mg/dL within 28 days prior to study entry.
8) MMSE score 18 within 28 days prior to study entry.
9) Patients must provide study specific informed consent prior to study entry.
10) Patients may have had prior therapy for brain metastasis, including radiosurgery and surgical resection. Patients should have completed prior therapy at least 14 days but no longer than 56 days prior to study entry.
11) Patients receiving systemic therapy are eligible for this study if given more > 14 days prior to study entry and given no sooner than >14 days post RT completion.
12) Negative serum pregnancy test (in women of childbearing potential) less than 7 days prior to study entry .
13) Women of childbearing potential and men who are sexually active must practice adequate contraception.
14) Complete history and general physical examination less than 28 days prior to study entry.
What is involved if I participate?
- How long is the study?
Duration: Memantine/placebo to be administered during and after WBRT for a total of 24 weeks. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Pretreatment Required Evaluations: 1. Sites are required to administer the neurocognitive assessments before the start of drug treatment. 2. Detailed neurological examination and physical examination within 7 days prior to beginning protocol treatment. 3. Steroid and anti-convulsant doses must be documented. 4. If the patient consents to participate in the Quality of Life component of the study, sites are required to administer the baseline quality of life questionnaire for the Functional Assessment of Cancer Therapy Brain (FACT-Br). 5. If the patient consents to participate in the translational research component of the study, sites are required to collect peripheral blood (serum/plasma/buffy coat) and urine at baseline. 6. Re-staging to confirm stability of systemic disease evaluated clinically, radiographically, and/or serologically, as appropriate for the underlying malignancy.
Who is the doctor administering the study?
Jeffrey A. Bogart, MD
Where will the study take place?
University Hospital, Hill Radiation Oncology, Oswego County Radiation Oncology
Over what time period is the study scheduled to run?
March 2008 to required sample size is reached
Who can I contact for more information?
- Name: Tara Mau
- Phone: 315-464-5264
- Email: maut@upstate.edu
- Fax: 315-464-5943
If you are interested in this trial, please contact the study coordinator or investigator noted above.
