Temozolomide and Procarbazine With Cilengitide for Patients With Glioblastoma Multiforme Without Methylation of the MGMT Promoter Gene

Phase 11 Study of Cilengitide in Combination With Concurrent Chemotherapy and Radiotherapy Followed by Protracted Daily Low Dose Temozolomide and Low Dose Procarbazine D1 - 20 in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Promoter Gene

NCT01124240•Northern Sydney and Central Coast Area Health Service

View on ClinicalTrials.gov

Summary

Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption. Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA \< 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week). After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA \< 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Newly diagnosed supratentorial GBM (WHO Grade IV,including GBM subtypes, e.g. gliosarcoma), histopathologically confirmed by central assessment as part of the screening for the CENTRIC trial.
•2. Males or females ≥18 years of age.
•3. Proven unmethylated MGMT gene promoter status, centrally assessed as part of the screening for the CENTRIC trial.
•4. Written informed consent for the present trial obtained before undergoing any study-related activities. The informed consent also allows access to all information obtained during the screening for the CENTRIC trial, notably the result of the MGMT testing.
•5. Available post-operative Gd-MRI performed within \<48 hours after surgery (in case it was not possible to obtain a Gd-MRI within \<48 hours post surgery, a Gd-MRI is to be performed prior to randomization).
•6. Stable or decreasing dose of steroids for \>5 days prior to randomization.
•7. ECOG PS of 0-1.
•8. Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
•9. Meets one of the following RPA classifications:
•* Class III (age \<50 years and ECOG PS 0).
+15 more criteria

Exclusion Criteria

•1. Prior chemotherapy within the last 5 years.
•2. Prior RTX of the head.
•3. Receiving concurrent investigational agents or has received an investigational agent(s) within the past 30 days prior to the first dose of Cilengitide .
•4. Prior systemic antiangiogenic therapy.
•5. Placement of Gliadel® wafer at surgery.
•6. Treatment with a prohibited concomitant medication.
•7. Planned surgery for other diseases (e.g. dental extraction).
•8. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
•9. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥ 5 years are eligible for this study.
•10. History of coagulation disorder associated with bleeding or recurrent thrombotic events.
+9 more criteria

Locations (1)

Royal North Shore Hospital

Sydney, New South Wales, Australia

Key Dates

Start Date

November 1, 2009

Primary Completion Date

November 1, 2012

Completion Date

January 1, 2014

Last Updated

July 26, 2011

Enrollment

ESTIMATED participants

Conditions

Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4

Interventions

Cilengitide

DRUG