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The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma

Phase 2
19 Years
70 Years
Not Enrolling
Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma

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Trial Information

The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma

Inclusion Criteria:

- Adult patients, greater than 18 years old.

- Surgically confirmed diagnosis of malignant glioma, specifically anaplastic glioma
(anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic
oligoastrocytoma [AOA]) or glioblastoma multiforme (GBM).

- Must have completed at least 2 cycles (2 months) of conventional 5/28 temozolomide,
with radiological evidence of progression.

- GBM treated with concurrent chemoradiation with temozolomide according to the
EORTC/NCIC (European Organization for Research & Treatment of Cancer/National Cancer
Institute of Canada) protocol.

- Evidence of progression confirmed radiologically (CT [computed tomography] or MRI
[magnetic resonance imaging]).

- Patients must be enrolled within 2 weeks of last radiological confirmation of
progression, except for patients undergoing surgical resection.

- Patients undergoing surgical resection for recurrent disease must be enrolled within
2 weeks of the post-surgical scan.

- Patients with no residual disease after surgery are allowed.

- Steroids dose should have been stabilized during the last 2 weeks prior to

- Use of medically approved contraception in fertile males and females.

- Women of childbearing potential must have a negative urine or serum pregnancy test
(urinary excretion or serum level of bHCG [beta human chorionic gonadotropin]) within
24 hours of inclusion in the study.

- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

- Signed informed consent form.

Exclusion Criteria:

- GBM progression during the first 2 months of adjuvant temozolomide (5/28).

- AA progression during the first 2 months of standard temozolomide therapy (5/28).

- Chemotherapy for the malignant glioma other than temozolomide.

- More than one prior course of chemotherapy with temozolomide.

- Patient evolving from anaplastic glioma to GBM following primary therapy.

- Patient older than 70 years or who received no conventional chemoradiation regimen.

- Patient who received radiotherapy for recurrent disease.

- Patient with metastatic disease.

- Known human immunodeficiency virus (HIV) infection.

- History of non-compliance to other therapies.

- Inadequate hematological, renal and hepatic function according to all of the
following laboratory values (to be performed within 14 days, inclusive, prior to
study inclusion):

- Absolute neutrophil count <=1.5 ×10^9/L;

- Platelets <=100 ×10^9/L;

- Hemoglobin <90 g/L;

- Serum creatinine >=1.5 times upper limit of laboratory normal (ULN);

- Total serum bilirubin >=1.5 times ULN;

- ASAT (AST [aspartate aminotransferase]) or ALAT (ALT [alanine aminotransferase) >2.0
times ULN;

- Alkaline phosphatase of >2.5 times ULN.

- Known chronic hepatitis B or hepatitis C infection.

- Any other serious medical condition, according to the medical judgment of the
physician prior to inclusion in the study.

- Any medical condition that could interfere with oral medication intake (e.g.,
frequent vomiting, partial bowel obstruction).

- Other malignancies during the previous 5 years with the exception of surgically cured
carcinoma in-situ of the cervix and basal cell carcinoma or non-melanoma skin cancer.

- Any psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule as discussed with
the patient before inclusion in the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.

Outcome Description:

Progression-free survival as determined by Kaplan-Meier method.

Outcome Time Frame:

6 months

Safety Issue:



Canada: Health Canada

Study ID:




Start Date:

June 2006

Completion Date:

September 2009

Related Keywords:

  • Glioma
  • Astrocytoma
  • Oligodendroglioma
  • Glioblastoma
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma