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A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component, Recurrent Glioblastoma, Relapsed Glioblastoma

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Trial Information

A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma


This Phase II study will enroll patients into two groups. Group 1 are patients who have
never been treated with bevacizumab. These patients will be randomly assigned to receive
either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for
Group 1 will be blinded. Group 2 patients are those who are refractory to bevacizumab
(experienced recurrence or progression of glioblastoma while on bevacizumab). These
patients will all receive rindopepimut/GM-CSF along with bevacizumab. Patients will be
treated until disease progression or intolerance and all patients will be followed for
survival. Patients may be treated with other therapies that are not part of the study
after discontinuing treatment with the study vaccine.


Inclusion Criteria:



Among other criteria, patients must meet the following conditions to be eligible for the
study:

1. Age ≥18 years of age.

2. Histologic diagnosis of glioblastoma (WHO Grade IV).

3. Previous treatment for glioblastoma must include surgery,conventional radiation
therapy and temozolomide (TMZ).

4. First or second relapse of de novo glioblastoma.

5. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at
least 12 weeks after radiation therapy.

6. KPS of ≥ 70%.

7. Life expectancy > 12 weeks.

8. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory.

9. If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of
dexamethasone or equivalent per day during the week prior to Day 1.

10. Evaluable disease

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the
study:

1. Subjects unable to undergo an MRI with contrast.

2. History, presence, or suspicion of metastatic disease

3. Prior receipt of vaccination against EGFRvIII.

4. Any known contraindications to receipt of study drugs, including known allergy or
hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®),
polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to
shellfish proteins.

5. Use of non-protein based investigational therapy within 14 days prior to Day 1 or use
of antibody-based investigational therapy within 28 days prior to Day 1.

6. Clinically significant increased intracranial pressure (e.g., impending herniation),
uncontrolled seizures, or requirement for immediate palliative treatment

7. Evidence of recent hemorrhage on screening MRI of the brain

8. Evidence of current drug or alcohol abuse.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate

Outcome Description:

Evaluate the antitumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the progression-free survival rate at 6 months post-Day 1 (PFS 6).

Outcome Time Frame:

6 months post-Day 1

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CDX110-06

NCT ID:

NCT01498328

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Glioblastoma
  • Small Cell Glioblastoma
  • Giant Cell Glioblastoma
  • Gliosarcoma
  • Glioblastoma With Oligodendroglial Component
  • Recurrent Glioblastoma
  • Relapsed Glioblastoma
  • EGFRvIII
  • Glioblastoma
  • Rindopepimut
  • CDX-110
  • Small cell
  • Giant cell
  • Brain Cancer
  • Brain Tumor
  • Gliosarcoma
  • oligodendroglial
  • radiotherapy
  • chemoradiation
  • Tumor
  • Bevacizumab
  • Relapsed
  • Returned
  • Recurrent
  • EGFR variant III
  • Glioblastoma
  • Gliosarcoma

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington Medical CenterSeattle, Washington  98195-6043
Rhode Island HospitalProvidence, Rhode Island  02903
Rush University Medical CenterChicago, Illinois  60612-3824
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Rochester Medical CenterRochester, New York  14642
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Atlanta Cancer CareAtlanta, Georgia  30342
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of FloridaGainesville, Florida  32610-0277
University of ChicagoChicago, Illinois  60637
Baylor Research InstituteDallas, Texas  75246
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195
Sparrow Cancer CenterLansing, Michigan  48912
University of Colorado, DenverAurora, Colorado  80045
NorthShore University health systemEvanston, Illinois  60201
Wake Forest Baptist HealthWinston-Salem, North Carolina  27157
Stanford Cancer Institute, Stanford UniversityStanford, California  94305
The Long Island Brain Tumor Center at Neurology Surgery, P.C.Great Neck, New York  11021
University of Cincinnati Cancer InstituteCincinnati, Ohio  45267
St. Joseph's Hospital and Medical Center / Barrow Neurological InstitutePhoenix, Arizona  85013
University of Southern California (USC) Norris Comprehensive Cancer CenterLos Angeles, California  90089
S. Nevada Cancer Research FoundationLas Vegas, Nevada  89106
The Preston Robert Tisch Brain Tumor Center; Duke University Medical CenterDurham, North Carolina  27710
Texas Oncology MidtownAustin, Texas  78705
UC Irvine Chao Family Comprehensive Cancer CenterOrange, California  92868
Legacy Research InstitutePortland, Oregon  97232