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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00629187
Recruitment Status : Terminated (The study was stopped due to lack of adequate enrollment.)
First Posted : March 5, 2008
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):
Tufts Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Central Nervous System Neoplasms Neoplasm Metastasis Drug: Temozolomide Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Study of Temozolomide With Autologous Stem Cell Rescue for Patients With Relapsed/Refractory CNS Malignancy Including Isolated Metastatic Disease
Study Start Date : April 2004
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Temozolomide
Before taking part in this study, subjects will have stem cells collected in a procedure called apheresis. Once on this study, subjects will be admitted to the hospital and receive daily doses of temozolomide by mouth for 5 days. Stem cells will be given back to subjects who will remain in the hospital until blood counts have recovered. Doses of temozolomide will range from 350 mg to 1500 mg/m(squared) daily for 5 days (total dose 1750 to 7500 mg/m(squared).
Other Name: Temodar

Primary Outcome Measures :
  1. Determine the maximum tolerated dose of temozolomide with hematopoietic stem cell rescue in patients with recurrent CNS malignancy [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Estimate the response rate, response duration and survival according to established response definitions [ Time Frame: 5 years ]
  2. Determine the pharmacokinetics of high daily dosing of temozolomide in the transplant setting [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00629187

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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
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Principal Investigator: Andreas Klein, MD Tufts Medical Center
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Responsible Party: Tufts Medical Center Identifier: NCT00629187    
Other Study ID Numbers: CN-306
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Tufts Medical Center:
Lung Neoplasm
Breast Neoplasm
Central Nervous System Neoplasms
Neoplasm Metastasis
Neoplasm Second Primary
Peripheral Blood Stem Cell Transplantation
Additional relevant MeSH terms:
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Neoplasm Metastasis
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents