Safety Study of High Dose Temozolomide to Treat Relapsed/Refractory Central Nervous System (CNS) Malignancy (CN-306)

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Tufts University

Status and phase

Terminated
Phase 1

Conditions

Neoplasm Metastasis
Central Nervous System Neoplasms

Treatments

Drug: Temozolomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00629187
CN-306

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Temozolomide

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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