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Status:

COMPLETED

Ramucirumab or Anti-PDGFR Alpha Monoclonal Antibody IMC-3G3 in Treating Patients With Recurrent Glioblastoma Multiforme

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Eli Lilly and Company

Conditions:

Adult Glioblastoma Multiforme

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal antibody IMC-3G3 (Olaratumab), can block tumor growth in different ways. Some block the ability of tumor cells to ...

Detailed Description

OBJECTIVES: Primary * 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 glioblastom...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/millimeter cubed (mm³)
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 gram/deciliter (g/dL)
  • Creatinine ≤ 1.5 milligram/deciliter (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 collection
  • International Normalized Ratio (INR) ≤ 1.5
  • Partial Thromboplastin Time (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 magnetic resonance imaging (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 requirements
  • 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 management
  • 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
  • PRIOR CONCURRENT THERAPY:
  • 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, thalidomide)
  • 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 Platelet-Derived Growth Factor Receptor (PDGFR)α/β, Platelet-Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), or Vascular Endothelial Growth Factor Receptor (VEGFR)s
  • 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, Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), or Interleukin (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 agents)
  • Concurrent steroids allowed

Exclusion

    Key Trial Info

    Start Date :

    July 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 4 2014

    Estimated Enrollment :

    80 Patients enrolled

    Trial Details

    Trial ID

    NCT00895180

    Start Date

    July 1 2010

    End Date

    March 4 2014

    Last Update

    December 27 2017

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    UAB Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294-3410

    2

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095

    3

    University of California San Francisco Medical Center

    San Francisco, California, United States, 94143

    4

    H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, United States, 33612-9497