Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02193347 : IDH1 Peptide Vaccine for Recurrent Grade II Glioma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02193347      |      Link to official Clinicaltrials.gov listing
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