16 Years and up
Accepting Healthy Volunteers?
- Histologically proven intracranial glioblastoma multiforme (WHO grade IV glioma) or
gliosarcoma. In addition, the Phase 1b cohort will include patients with progressive
WHO grade III glioma.
- Patients will be eligible if the original histology was lower grade glioma and a
subsequent diagnosis of glioblastoma or gliosarcoma is made.
- Unequivocal radiographic evidence for tumor progression by MRI. It is understood that
some patients may be resected prior to enrolling onto protocol
- Patients must have completed a course of radiation therapy and at least 2 adjuvant
cycles of temozolomide for the phase 2 component.
- Patients enrolling onto Cohort 2b who have been taken off bevacizumab must have had at
least a 28 day washout from any previous administration of bevacizumab. It is
preferred that patients who fail bevacizumab prior to trial entry remain on
bevacizumab in the trial.
- Prior temozolomide is not required for the phase 1 component; prior radiation is
required for the phase 1 arm.
- Patients must be on a steroid dose less than or equal to 2 mg of dexamethasone daily
(or equivalent), and this dose must not have increased for at least 14 days prior to
obtaining the enrollment.
- ECOG performance status ≤1 or Karnofsky ≥70%.
- Age between 16
- Must be 28 days from the administration of any investigational agent or prior
cytotoxic therapy with the following exceptions:
- Must be 14 days from administration of non-cytotoxic agents (e.g., bevacizumab (except
COHORT 2b), interferon, tamoxifen, thalidomide, cis-retinoic acid, tyrosine kinase
- Prior invasive malignancy that is not low-grade glioma, high-grade glioma,
glioblastoma, or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ
of the cervix) unless the patient has been disease free and off therapy for that
disease for a minimum of 3 years.
- Patients on the phase 2 portion of the study may not have more than 2 prior regimens
for recurrent disease for glioblastoma/gliosarcoma. Patients on the phase 1 portion of
the study may not have had more than 3 prior regimens.
- Systemic corticosteroid therapy > 2 mg of dexamethasone daily (or equivalent) at study
- Active or history of autoimmune disease