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 (P04601AM1)(COMPLETED)

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392171
• Other study ID #: P04601
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2006
• Last updated: June 3, 2010
• Start date: June 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2010
• Source: Schering-Plough
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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 (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m^2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 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 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.

Study Design

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

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioma
• Oligodendroglioma

Intervention

Drug:
• Temozolomide
Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Schering-Plough

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.	Progression-free survival as determined by Kaplan-Meier method.	6 months	No