Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tufts Medical Center
High dose chemotherapy and autologous stem cell transplant is an accepted treatment alternative for patients with brain tumors. Temozolomide has been approved for use by the United States Food and Drug Administration (FDA) for certain tumors of the brain. The doses of temozolomide given in this study will be higher than approved by the FDA and higher than those given in any prior studies.
Over 25 subjects will be enrolled on this study over a period of 5 years. This study will only be available at Tufts Medical Center.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients or their health care proxies must be able to provide consent to participate in this trial.
Patients must have one of the following diagnoses which has not responded or recurred following at least one prior chemotherapy regimen or radiation therapy:
* anaplastic astrocytoma, glioblastoma multiforme or oligodendroglioma
* primary CNS lymphoma
* malignant disease metastatic to the CNS
Patients must be candidates for high dose chemotherapy and autologous stem cell transplant according to the following criteria:
* Patients must be between the ages of 18 and 70 years (inclusive)
* Patients must have a left ventricular ejection fraction greater than or equal to 45% by MUGA or echocardiogram
* Patients must have adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of predicted
* Patients must have serum direct bilirubin less than or equal to 2.0 mg/dl and transaminases less than or equal to 3x institutional upper limit of normal
* Patients must have serum creatinine less than or equal to 2 mg/dl with creatinine clearance greater than or equal to 60 ml/min (either calculated or measured)
* Patients must have an ECOG performance status between 0 and 2
Patients must be at least 4 weeks from last cytoreductive chemotherapy.
Expected survival of at least 3 months
You may not be if
Patients with uncontrolled metastatic disease outside of the CNS which would itself, in the investigator's opinion, limit survival to less than 6 months
Patients with uncontrolled seizures are ineligible.
Patients with a history of myocardial infarction within the preceding 6 months, significant arrhythmia within the preceding 3 months, or uncontrolled hypertension or congestive heart failure are ineligible.
Patients with unstable angina are ineligible.
Pregnant or lactating women are ineligible.
Male and female patients who do not agree to practice approved methods of birth control for the duration of the study are ineligible.
Patients with uncontrolled, active infection are ineligible.
