Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

Status: Recruiting
Phase: Phase 3
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01480479 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-308

 

This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital

Overall PI:
Jennifer Bellon, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: Among other criteria, patients must meet the following conditions to be eligible for the study: 1. Adult patients, ≥ 18 years old 2. Newly diagnosed glioblastoma 3. Attempted surgical resection followed by conventional chemoradiation 4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory 5. No evidence of progressive disease from the post-operative period to the post-chemoradiation period 6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy 7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization 8. WHO-ECOG Performance Status ≤ 2 Exclusion Criteria: Among other criteria, patients who meet the following conditions are NOT eligible for the study: 1. Stereotactic biopsy only (without further surgical resection) 2. Presence of diffuse leptomeningeal disease or gliomatosis cerebri 3. History, presence, or suspicion of metastatic disease 4. Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide 5. Active systemic infection requiring treatment 6. History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer or cured, early-stage prostate cancer in a patient with PSA level less than the upper limit of normal 7. Planned major surgery 8. Evidence of current drug or alcohol abuse 9. 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
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