Status:
COMPLETED
Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
Celldex Therapeutics
Conditions:
Glioblastoma
Small Cell Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug temozolomide can help improv...
Eligibility Criteria
Inclusion
- Inclusion Criteria-
- Among other criteria, patients must meet the following conditions to be eligible for the study:
- Adult patients, ≥ 18 years old
- Newly diagnosed glioblastoma
- Attempted surgical resection followed by conventional chemoradiation
- Documented EGFRvIII positive tumor status by a Sponsor designated laboratory
- No evidence of progressive disease from the post-operative period to the post-chemoradiation period
- Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy
- Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
- WHO-ECOG Performance Status ≤ 2
- Patients of childbearing/reproductive potential will be instructed to use birth control as defined by your doctor.
- Exclusion Criteria-
- Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- Stereotactic biopsy only (without further surgical resection)
- Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.
- History, presence, or suspicion of metastatic disease
- Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
- Active systemic infection requiring treatment
- 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, cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other carcinoma in situ that has been adequately treated and cured.
- Planned major surgery
- Evidence of current drug or alcohol abuse
- 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
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial
- Women who are pregnant or lactating
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
745 Patients enrolled
Trial Details
Trial ID
NCT01480479
Start Date
November 1 2011
End Date
November 1 2016
Last Update
January 16 2018
Active Locations (223)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
3
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
4
University of Arizona Health Network
Tucson, Arizona, United States, 85724