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An Open Label, Phase 2 Study Evaluating the Safety and Efficacy of IMC-3G3 or IMC-1121B in Patients With Recurrent Glioblastoma Multiforme

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

An Open Label, Phase 2 Study Evaluating the Safety and Efficacy of IMC-3G3 or IMC-1121B in Patients With Recurrent Glioblastoma Multiforme



- To assess the progression-free survival rate at 6 months after treatment with
ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 in patients with recurrent
glioblastoma multiforme.


- To evaluate the acute and late toxicities associated with these regimens.

- To assess the objective tumor response rate.

- To estimate the overall survival of these patients.

- To describe the pharmacokinetic and pharmacodynamic profiles and immunogenicity of
these regimens.

OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 2 treatment

- Group 1: Patients receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity.

- Group 2: Patients receive anti-PDGFR alpha monoclonal antibody IMC-3G3 IV over 60-90
minutes on day 1. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.

Patients undergo blood sample collection periodically for pharmacokinetic, pharmacodynamic
biomarker (i.e., PDGFRα, PDGF, VEGF, VEGFR-1, and VEGFR-2), and immunogenicity analyses.

After completion of study treatment, patients are followed every 2 months.

Inclusion Criteria


- Histologically confirmed supratentorial glioblastoma multiforme (GBM)

- Patients with prior low-grade glioma who progressed after radiotherapy ±
chemotherapy and are biopsied and found to have GBM are eligible

- Progressive or recurrent disease after radiotherapy ± chemotherapy

- Measurable disease by contrast-enhanced MRI or CT scan


- Karnofsky performance status 60-100%

- Life expectancy ≥ 3 months

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

- Total bilirubin ≤ 1.5 mg/dL

- Transaminases ≤ 3 times upper limit of normal (ULN)

- Urine protein ≤ 2+ by dipstick or urinalysis or ≤ 1,000 mg by 24-hour urine

- INR ≤ 1.5

- PTT ≤ 5 seconds above ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 12 weeks after
completion of study treatment

- Mini Mental State Exam score ≥ 15

- Able to undergo MRI (i.e., no pacemaker, aneurysm clip, or claustrophobia)

- No concurrent serious infection or medical illness that would jeopardize the ability
of the patient to receive the treatment outlined in this study with reasonable safety
including, but not limited to, any of the following:

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situation that would limit compliance with study

- No other malignancy within the past 5 years, except curatively treated carcinoma in
situ or basal cell carcinoma of the skin

- No major bleeding episode within the past 3 months

- No myocardial infarction, unstable angina pectoris, cerebrovascular accident, or
transient ischemic attack within the past 6 months

- No serious or non-healing wound, ulcer, or bone fracture

- No uncontrolled or poorly controlled hypertension, despite standard medical

- No known allergy to any of the treatment components

- No known HIV positivity or AIDS-related illness

- No uncontrolled thrombotic or hemorrhagic disorders

- No grade 3-4 gastrointestinal bleeding within the past 3 months

- No gross hemoptysis (≥ ½ teaspoon) within the past 2 months


- See Disease Characteristics

- Recovered from prior therapy

- At least 3 months since prior radiotherapy

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- At least 2 weeks since prior FDA-approved, non-cytotoxic agents (e.g., celecoxib,

- At least 3 weeks since prior investigational, non-cytotoxic agents

- More than 28 days since prior major surgery, including brain biopsy

- More than 7 days since prior subcutaneous venous access device placement

- No prior treatment with other agents that directly inhibit PDGFRα/β, PDGF, VEGF, or

- No concurrent therapeutic anticoagulation, chronic daily treatment with aspirin (>
325 mg/day), or other known inhibitors of platelet function

- No concurrent prophylactic hematopoietic growth factors (e.g., erythropoietin, G-CSF,
GM-CSF, or IL-11) during the first course of treatment

- No concurrent elective or planned surgery

- No other concurrent therapy for the tumor (e.g., chemotherapy or investigational

- Concurrent steroids allowed

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival rate at 6 months

Outcome Time Frame:


Safety Issue:


Principal Investigator

Jaishri O. Blakeley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

ABTC-0901 CDR0000641230



Start Date:

July 2010

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Emory University Hospital - Atlanta Atlanta, Georgia  30322
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Massachusetts General Hospital Boston, Massachusetts  02114-2617
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
UCSF Medical Center at Parnassus San Francisco, California  94143-0296
University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania  15232