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Phase I Dose Escalation Study of Temozolomide With Autologous Stem Cell Rescue for Patients With Relapsed/Refractory CNS Malignancy Including Isolated Metastatic Disease


Phase 1
18 Years
70 Years
Not Enrolling
Both
Central Nervous System Neoplasms, Neoplasm Metastasis

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Trial Information

Phase I Dose Escalation Study of Temozolomide With Autologous Stem Cell Rescue for Patients With Relapsed/Refractory CNS Malignancy Including Isolated Metastatic Disease


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose of temozolomide with hematopoietic stem cell rescue in patients with recurrent CNS malignancy

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Andreas Klein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center

Authority:

United States: Institutional Review Board

Study ID:

CN-306

NCT ID:

NCT00629187

Start Date:

April 2004

Completion Date:

April 2012

Related Keywords:

  • Central Nervous System Neoplasms
  • Neoplasm Metastasis
  • Lung Neoplasm
  • Breast Neoplasm
  • Melanoma
  • Central Nervous System Neoplasms
  • Neoplasm Metastasis
  • Neoplasm Second Primary
  • Peripheral Blood Stem Cell Transplantation
  • Neoplasms
  • Neoplasm Metastasis
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Tufts Medical CenterBoston, Massachusetts  02111