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TerminatedNCT00629187CN-306Updated Apr 27, 2012

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

A Phase 1 interventional study of Temozolomide in Central Nervous System Neoplasms and Neoplasm Metastasis, sponsored by Tufts Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-04-27.

Sponsored by Tufts Medical Center · Phase 1, Interventional, and Treatment

Why this study was terminated
The study was stopped due to lack of adequate enrollment.
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Central Nervous System Neoplasms
  • Neoplasm Metastasis

Keywords

  • Lung Neoplasm
  • Breast Neoplasm
  • Melanoma
  • Central Nervous System Neoplasms
  • Neoplasm Metastasis
  • Neoplasm Second Primary
  • Peripheral Blood Stem Cell Transplantation
03

In context

Central Nervous System Neoplasms

684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.

This study's enrollment of 2 is below the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 200 studies on the registry; 29 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 16 (52%) have results posted.

Browse Tufts Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    1

    Drug: Temozolomide

Interventions

  • DrugTemozolomide

    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).

    Also known as: Temodar

06

What researchers measure

Primary outcomes

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

    Time frame: 5 years

Secondary outcomes

  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

07

Study locations

1 site
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00629187
Lead sponsor
Tufts Medical Center
Responsible party
Sponsor
First posted
Mar 5, 2008
Start date
Apr 2004
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Apr 27, 2012

Study contacts

Andreas Klein, MD
principal investigator · Tufts Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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