A Phase II Study to Treat Advanced Malignant Glioma

NCT ID: NCT00427440

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma.

Conditions

Advanced Malignant Glioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMG 102 at 10 mg/kg Dose Level

Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.

Group Type: EXPERIMENTAL

AMG 102 at 10 mg/kg

Intervention Type: DRUG

AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks

AMG 102 at 20 mg/kg Dose Level

Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.

Group Type: EXPERIMENTAL

AMG 102 at 20 mg/kg

Intervention Type: DRUG

AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks

Interventions

AMG 102 at 20 mg/kg

AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks

Intervention Type: DRUG

AMG 102 at 10 mg/kg

AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• subjects with documented histologically confirmed primary grade 4 advanced malignant glioma
• no more than 3 prior relapses or prior systemic treatments
• recurrent disease documented by MRI after prior therapy
• must have at least one site of bidimensionally measurable disease:
• archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment
• age ≥ 18 years
• Karnofsky performance score ≥ 60%
• hemoglobin ≥ 10 g/dL
• absolute neutrophil count ≥ 1.5 x 10(9th)/L
• platelet count ≥ 100 x 10(9th)/L
• serum creatinine ≤ 1.5 times upper limit of normal
• alanine aminotransferase ≤ 2.5 times upper limit of normal
• serum total bilirubin ≤ 2.5 times upper limit of normal
• before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria

• history of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) within 6 months before enrollment
• evidence of acute intracranial/intratumoral hemorrhage; except for subjects with stable grade 1 hemorrhage
• received radiation therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such therapy
• treated previously with any c-Met or HGF targeted therapy
• treated with thalidomide or tamoxifen within 1 week before enrollment or has not recovered from the toxic effects of such cancer therapy
• treated with immunotherapeutic agents, vaccines or mAb therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such cancer therapy
• treated with alkylating agents within 4 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy
• treated with chemotherapy (non-alkylating agents) within 2 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy
• surgical resection of brain tumor within 4 weeks before enrollment or have not recovered from acute side effects of such therapy, except for neurological effects
• plans to receive surgery, radiation therapy or other elective surgeries during the course of the study
• concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study
• active infection within 7 days before enrollment
• past or current history of another neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative or adjuvant treatment administered for the last 3 years
• documented history of human immunodeficiency virus
• documented history of chronic viral hepatitis
• concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except:

• Use of low molecular weight heparins (LMWH, e.g., enoxaparin sodium [Lovenox] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed
• Use of low dose warfarin (< 2 mg/day) for prophylaxis against central venous catheter thrombosis is allowed
• currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapeutic study(s)
• had major surgery within 4 weeks before enrollment or recovering from prior surgery
• known allergy or sensitivity to any of the excipients in the investigational product
• pregnant or breast feeding
• unwilling to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product, for:

• male subjects
• female subjects who are not post-menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this exclusion
• previously treated with AMG 102
• previously enrolled into this study
• will not be available for follow-up assessment
• has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Wen PY, Schiff D, Cloughesy TF, Raizer JJ, Laterra J, Smitt M, Wolf M, Oliner KS, Anderson A, Zhu M, Loh E, Reardon DA. A phase II study evaluating the efficacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma. Neuro Oncol. 2011 Apr;13(4):437-46. doi: 10.1093/neuonc/noq198. Epub 2011 Feb 4.

Reference Type: BACKGROUND

PMID: 21297127 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20050253

Identifier Type: -

Identifier Source: org_study_id