Status:
COMPLETED
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
Lead Sponsor:
Katy Peters, MD, PhD
Conditions:
Brain Cancer
Brain Neoplasm, Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the sa...
Detailed Description
After informed consent has been signed, subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly into the deltoid muscle to ensure...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- IDH1R132H expression in primary tumor
- Radiographic and/or clinical progressive and resectable Grade II glioma.
- Signed informed consent.
- For females of child-bearing potential, negative serum pregnancy test at screening (within 48 hours prior to leukapheresis)
- Women of childbearing potential and male participants must agree to practice adequate contraception.
- Karnofsky Performance Status (KPS) of ≥ 70.
- Complete Blood Count (CBC)/differential with adequate bone marrow function as defined below within 2 weeks of enrollment:
- Absolute neutrophil count, ≥ 1500 cells/mm3.
- Platelet count, ≥ 100,000 cells/mm3.
- Hemoglobin ≥ 10 g/dl. (Note: the use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
- Adequate renal function as defined below within 2 weeks of enrollment:
- Blood Urea Nitrogen (BUN) ≤ 25 mg/dl.
- Creatinine ≤ 1.7 mg/dl.
- Adequate hepatic function as defined below within 2 weeks of enrollment:
- Bilirubin ≤ 2.0 mg/dl.
- Alanine Aminotransferase (ALT) ≤ 3 x normal range.
- Aspartate Aminotransferase (AST) ≤ 3 x normal range
Exclusion
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)
- Metastases detected below the tentorium or beyond the cranial vault.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization.
- Myocardial infarction within the last 6 months.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because treatments involved in this protocol may be significantly immunosuppressive.
- Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug.
- Prior allergic reaction to temozolomide.
- Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.
- Patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine®.
- Allergy or hypersensitivity to tetanus vaccine or any component of the tetanus vaccine.
- Unable to undergo MRI imaging.
Key Trial Info
Start Date :
January 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02193347
Start Date
January 28 2016
End Date
February 3 2020
Last Update
December 1 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710