Clinical trial NCT00566852 (phase 3, status: completed)
Conditions: cognitive/functional effects, metastatic cancer, neurotoxicity, unspecified adult solid tumor, protocol specific
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, G92.00, G92.01, G92.02, G92.03, G92.04, G92.05, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: memantine
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within
             the past 5 years

               -  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)

               -  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

               -  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:

        Inclusion

          -  Karnofsky performance status 70-100%

          -  Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min

          -  Total bilirubin ≤ 2.5 mg/dL

          -  Blood urea nitrogen (BUN) < 20 mg/dL

          -  Mini-mental status exam score ≥ 18

          -  Negative serum pregnancy test

          -  Fertile patients must practice adequate contraception

        Exclusion

          -  Severe, active co-morbidity, defined as follows:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the last 6 months

               -  Transmural myocardial infarction within the last 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time
                  of registration

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy at the time of registration

               -  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:

        Inclusion

          -  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)

        Exclusion

          -  Prior cranial radiotherapy

               -  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