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Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma

Phase 2
18 Years
Not Enrolling
Recurrent Central Nervous System Neoplasm

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Trial Information

Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma



- Determine the efficacy, as measured by 6-month progression-free survival, of a
dose-intense temozolomide treatment schedule in patients with recurrent high-grade


- Assess the toxicities of this dose-intense temozolomide.

- Determine the overall survival of patients treated with this dose-intense schedule.

- Determine whether methylation status of the MGMT gene within patients' tumors predicts
greater efficacy (progression-free survival), in patients treated on this protocol.

- Determine whether patients' tumors have functional alterations of the mismatch repair
(MMR) system by PCR analysis for microsatellite instability (MSI) and whether such
alterations may influence outcome in patients treated on this protocol.

- Determine how initial success with temozolomide may influence outcome in recurrent
patients treated on this protocol by evaluating patients progressing after two
first-line adjuvant courses of temozolomide, patients progressing within 6 months after
the 6th adjuvant course of temozolomide, and patients progressing 6 months after
temozolomide is voluntarily discontinued.

OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and days 15-21. Treatment
repeats every 28 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

Formalin-fixed paraffin-embedded tissue blocks or unstained paraffin slides from available
surgical samples are evaluated for molecular abnormalities in the tumor, including (but not
limited to) MGMT status and microsatellite instability.

After completion of study therapy, patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 40 patients with WHO II grade 4 tumors (glioblastoma
multiforme [GBM]) and 20 patients with WHO II grade 3 tumors (non-GBM) will be accrued for
this study.

Inclusion Criteria

Inclusion Criteria

- Patients with radiographically proven recurrent, intracranial malignant glioma will
be eligible for this protocol.

- All patients must sign an informed consent

- Patients must have had external beam radiation; there is no limit to the number of
prior chemotherapies used.

- Patients must be > 18 years old, and with a life expectancy > 8 weeks.

- Patients must have a Karnofsky performance status of > 60.

- At the time of registration: Patients must have recovered from the toxic effects of
prior therapy:

- Patients must have adequate bone marrow function.

- Patients must have shown unequivocal radiographic evidence for tumor progression by

- Patients having undergone recent resection of recurrent or progressive tumor will be
eligible as long as all of the following conditions apply: They have recovered from
the effects of surgery. Residual disease following resection of recurrent
intracranial malignant glioma is not mandated for eligibility into the study.

- Patients must have failed prior radiation therapy and must have an interval of
greater than or equal to 42 days from the completion of radiation therapy to study

- Patients with prior therapy that included interstitial brachytherapy, stereotactic
radiosurgery, or Gliadel wafers must have confirmation of true progressive disease
rather than radiation necrosis based upon either PET or MR spectroscopy or surgical
documentation of disease.

- Male and female patients with reproductive potential must use an approved
contraceptive method

Exclusion Criteria

- Patients must not have any significant medical illnesses that in the investigator's
opinion cannot be adequately controlled with appropriate therapy or would compromise
the patient's ability to tolerate this therapy

- Patients with a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission and off of all therapy
for that disease for a minimum of 3 years are ineligible.

- Patients must not have active infection or serious intercurrent medical illness.

- Patients must not be pregnant/breast feeding and must agree to practice adequate

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy, as measured by 6-month progression-free survival, of the dose-intense temozolomide treatment schedule

Outcome Time Frame:

Study start was 10.31.2007. Enrollment was completed on 12/22/2011

Safety Issue:


Principal Investigator

Nicholas A. Butowski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Data and Safety Monitoring Board

Study ID:




Start Date:

October 2007

Completion Date:

September 2012

Related Keywords:

  • Recurrent Central Nervous System Neoplasm
  • adult glioblastoma
  • adult gliosarcoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • recurrent adult brain tumor
  • Neoplasms
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115