IDH1 Peptide Vaccine for Recurrent Grade II Glioma

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary Archer Ph.D.
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

1. Age ≥ 18 years.

2. IDH1R132H expression in primary tumor

3. Radiographic and/or clinical progressive and resectable Grade II glioma.

4. Signed informed consent.

5. For females of child-bearing potential, negative serum pregnancy test at screening (within 48 hours prior to leukapheresis)

6. Women of childbearing potential and male participants must agree to practice adequate contraception.

7. Karnofsky Performance Status (KPS) of ≥ 70.

8. 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.)

9. Adequate renal function as defined below within 2 weeks of enrollment:

• Blood Urea Nitrogen (BUN) ≤ 25 mg/dl.

• Creatinine ≤ 1.7 mg/dl.

10. 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 Criteria:

1. 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.)

2. Metastases detected below the tentorium or beyond the cranial vault.

3. 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.

4. Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug.

5. Prior allergic reaction to temozolomide.

6. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.

7. Patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine®.

8. Allergy or hypersensitivity to tetanus vaccine or any component of the tetanus vaccine.

9. Unable to undergo MRI imaging.