Return to search results.
Complete title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
|Research Study Number||20111531|
|Principal Investigator||Maciej Mrugala, MD, PhD|
Research Study Description
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.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Stereotactic biopsy only (without further surgical resection)
- Presence of diffuse leptomeningeal disease or gliomatosis cerebri
- 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 or cured, early-stage prostate cancer in a patient with PSA level less than the upper limit of normal
- 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
Other exclusion criteria may apply.
Astrocytomas; Brain Cancer; Glioblastoma Multiforme; Glioma; Solid Tumors
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.