Status:
COMPLETED
The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Glioma
Astrocytoma
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide ...
Eligibility Criteria
Inclusion
- 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 enrollment.
- 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
- 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.
Key Trial Info
Start Date :
June 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00392171
Start Date
June 9 2006
End Date
September 15 2009
Last Update
June 7 2017
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