Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Celldex Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Drug: Rindopepimut (CDX-110) with GM-CSF
  • Drug: Temozolomide
  • Drug: KLH

Phase:

Phase 3

Eligibility


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

   9. 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:

   1. Stereotactic biopsy only (without further surgical resection)

   2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial
   disease.

   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,
   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.

   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

10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
   that could increase the risk associated with participating in a clinical trial

11. Women who are pregnant or lactating

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting