CT-322 in Combination With Radiation Therapy and Temozolomide to Treat Newly Diagnosed Glioblastoma Multiforme

Status unconfirmed · Phase 1

Conditions studied: Glioblastoma Multiforme

In brief

Rationale: In light of the demonstrated activity of anti-angiogenesis agents in rGBM, it is reasonable to postulate that adding these agents to standard RT and chemotherapy in the up-front management of newly diagnosed GBM may improve the clinical benefit. This study will examine the safety and tolerability of adding CT-322 to the standard radiation therapy/temozolomide (RT/TMZ) backbone of treatment for newly diagnosed GBM

Key facts

Study ID: NCT00768911
Run by: Adnexus, A Bristol-Myers Squibb R&D Company
People needed: 30
Starts: 2008-10-01
Expected to finish: 2011-06-01
Last updated by the study team: 2010-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Informed consent
18 years or older
Newly diagnosed, histologically confirmed GBM (grade IV astrocytoma):
Subjects will not be eligible if the original histology was a lower grade glioma and a subsequent histological diagnosis of a GBM is made
Central independent pathology confirmation of GBM, concurrent with subject enrollment
Subjects with sufficient biopsy material available to perform PCR analysis for MGMT promoter methylation must have tissue submitted to the designated laboratory for analysis. Subjects with insufficient tissue or indeterminate results will remain eligible for enrollment.
KPS ≥ 60
Be able to begin treatment with RT/TMZ within 6 weeks after biopsy or craniotomy with satisfactory wound healing prior to initiating treatment with CT-322
Be able to undergo serial MRIs:
Measurable or assessable disease may or may not be present
CT scanning may not substitute for MRI scanning
Have adequate bone marrow, liver, renal, and metabolic function as assessed by the following:
Hemoglobin ≥ 10.0 g/dL (unsupported)
Absolute neutrophil count (ANC) ≥ 1,500/mm3 (unsupported)
Platelet count ≥ 100,000/mm3 (unsupported)
Total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's disease
ALT and AST ≤ 3 x ULN
INR < 1.5 or PT within normal limits; and PTT within normal limits
Serum creatinine ≤ 1.5 x ULN
Urine protein/creatinine ratio (UPCR) < 1.0
Serum amylase and lipase ≤ 1.5 x the ULN
2-dimensional echo or MUGA scan with LVEF within the institutional normal range
Stable or decreasing dose of corticosteroids for at least 1 week prior to screening MRI
Contraceptive measures for male and female participants for the duration of treatment and for 4 weeks following discontinuation of study treatment:
-Female subjects having reproductive potential must have a negative serum pregnancy test within 72 hours before first administration of CT-322

You may not qualify if…

Prior CT-322 therapy or prior therapy with another VEGF-modulating agent (marketed or investigational) for malignant glioma
History of hypersensitivity to TMZ or any of its excipients, or to Dacarbazine (DTIC)
Prior treatment for GBM, except surgical resection and/or corticosteroid therapy
Prior radiotherapeutic, or local (intra-tumoral) or systemic medical therapies (including but not limited to: chemotherapy, hormonal therapy, immunotherapy, anti-angiogenic therapy, implantable Gliadel® wafers, and molecularly targeted therapy) for brain tumors
Current enrollment in another therapeutic clinical trial involving ongoing therapy
Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study such as:
Pleural or pericardial effusion of ≥ grade 2
Uncontrolled diabetes, despite optimal medical management, according to the opinion of the investigator
Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management)
Any active craniotomy-related wound infection
Active clinically significant infection (> grade 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) requiring the use of anti-microbial agents, or that would be otherwise, in the opinion of the investigator, interfere with the ability of the subject to participate
History of clinically significant bleeding diathesis or coagulopathy including platelet function disorder (e.g., known hemophilia or von Willebrand disease) or acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding untreated or recurring
Untreated peptic ulcer disease or peptic ulcer disease treated for < 3 months
Non-healing wound (including craniotomy wound), ulcer, or bone fracture; or
Glomerulonephritis or other protein-wasting glomerulopathy
Within 12 months before enrollment had:
Thrombotic or embolic cerebrovascular accident or transient ischemic attacks
CNS bleed (other than stable, grade 1)
Intraocular bleed, or any medical condition, which in the opinion of the investigator increases the risk for intra-ocular bleeding
Septic endocarditis (unless deemed cured and off all antibiotic therapy for at least 3 months)
Coronary artery bypass graft, angioplasty, vascular stenting, myocardial infarction, unstable angina; or
Symptomatic congestive heart failure (New York Heart Association ≥ class II)
Any intraparenchymal CNS hemorrhage at the time of enrollment except for:
Grade 1 intraparenchymal hemorrhage in the immediate post-operative period, or

Where it is running

University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
University of Chicago Medical Center — Chicago, Illinois, United States
University of Kentucky Hospital — Lexington, Kentucky, United States
Washington University Cancer Center — St Louis, Missouri, United States
SUNY Upstate Medical University — Syracuse, New York, United States
Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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