Trial Search Results

Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Drug: Memantine
  • Other: Placebo
  • Radiation: Whole brain radiation therapy

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting