Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) Malignancy

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to find the maximum dose of a drug, temozolomide, that can safely be given to subjects with brain tumors. Past studies showed that the maximum dose of temozolomide was limited by low blood counts. The investigators will use blood stem cells collected from bone marrow to help subjects recover their blood counts, a procedure called autologous stem cell transplant or stem cell rescue. This way, the investigators expect to be able to safely deliver very high doses of temozolomide. This study is only available at Tufts Medical Center.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Patients infected with HIV are ineligible.