Glioblastoma
Conditions
Brief summary
Data from clinical trials suggest that SurVaxM administered as a single agent, or in combination with standard glioblastoma chemotherapy treatment regimens to patients with recurrent or newly diagnosed glioblastoma, is generally well tolerated and may increase progression free survival and overall survival in some patients
Interventions
DRUGSurVaxM
Each participant will receive 4 doses of SVN53-67/M57-KLH (SurVaxM) spaced two weeks apart. This phase of treatment is known as the prime-boost phase and will take 6 weeks to complete. After completion of the prime-boost phase of treatment, the participant will receive a dose ofSVN53-67/M57-KLH (SurVaxM) every 3 months for up to two years
Sponsors
Roswell Park Cancer Institute
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
This EAP is intended for the following patients only: * Roswell Park patients with glioblastoma who are not eligible for an appropriate clinical trial for their glioblastoma, but who meet required eligibility criteria listed herein and, * Roswell Park patients with glioblastoma who have completed participation in a nonrandomized clinical trial of SurVaxM, but who wish to continue to receive SurVaxM as part of their ongoing care, and who meet all other eligibility criteria listed herein and, * Patients at institutions other than Roswell Park who have completed treatment on a nonrandomizedclinical trial of SurVaxM at their participating institution, but who wish to continue to receive SurVaxM as part of their ongoing care, and who meet all other eligibility criteria listed herein. Such patients must agree to, and be able to, participate at Roswell Park. Inclusion Criteria: * Patient has newly diagnosed or recurrent or progressive glioblastoma who falls under one or more
Exclusion criteria
of another SurVaxM clinical study currently recruiting, or has completed participation in another non-randomized clinical trial of SurVaxM for glioblastoma and is off study but wishes to receive SurVaxM as part of his/her treatment * Karnofsky performance status ≥ 70 (refer to Appendix A). * A pathologically confirmed diagnosis of glioblastoma of the brain or spinal cord is required, unless biopsy is determined by the PI not to be in the patient's best interest. * Have the following clinical laboratory values obtained within 28 days prior to registration: * Absolute neutrophil count (ANC) ≥ 1.0 x 109/L * Creatinine ≤ 1.8 mg/dL * Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin or oral anticoagulants) must meet the following criteria: * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., coagulopathy) * For participants of child-bearing potential: must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to enrollment and, have a negative pregnancy test prior to starting treatment under this protocol. * Dose of corticosteroids reduced to the minimum required to control neurologic symptoms. * Patients with newly diagnosed glioblastoma must have completed radiation therapy and temozolomide or standard of care treatment of their glioblastoma, unless it is determined by their treating physician that it is not in the best interest of the patient to do so. * Participant must understand the investigational nature of this study drug and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving SurVaxM. * Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
Outcome results
None listed