Phase
Condition
Oligodendroglioma
Treatment
Td vaccine
TTRNA-DC vaccines with GM-CSF
TTRNA-xALT
Clinical Study ID
Ages 18-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, aged 18 years and above
Tumor tissue obtained on a screening consent is available.
Confirmed with recurrent/progressive IDH-mutant 1p/19q co-deleted OligodendrogliomaWHO grade 2 or WHO grade 3, more than 12 weeks from completion of radiation.
Karnofsky Performance Status ≥ 60
Must be a candidate for surgery/biopsy
Adequate bone marrow and organ function as defined below:
ANC ≥ 1,000/mcL
Platelets ≥ 100,000/mcL
Hemoglobin ≥ 9 g/dL (can be transfused)
Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 60mL/min for patients with serum creatinine > 1.5 x IULN
Serum total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients withtotal bilirubin > 1.5 x IULN
AST (SGOT) and ALT (SGPT) ≤ 3 x IULN
For females of childbearing potential, negative serum pregnancy test at enrollment
For women and men of childbearing potential (WOCBP) must be willing to useacceptable contraceptive methods
Exclusion
Exclusion Criteria:
Disease progression during treatment with an anti-IDH-1 or anti IDH-2
Prior invasive malignancy (except for non-melanomatous skin cancer) unless diseasefree for ≥ 3 years.
Metastases detected below the tentorium or beyond the cranial vault andleptomeningeal involvement.
Multifocal disease.
Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
HIV, Hepatitis B, or Hepatitis C seropositive.
Known active infection or immunosuppressive disease.
Autoimmune disease requiring medical management with immunosuppressant.
Pregnancy or lactation, due to possible adverse effects on the developing fetus orinfant.
Treatment with another investigational drug or other intervention within 30 daysprior to projected first dose of study treatment (Priming phase with TTRNA-DC).
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization.
Transmural myocardial infarction within the last 6 months.
Acute bacterial or fungal infection requiring intravenous antibiotics at timeof enrollment.
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illnessrequiring hospitalization or precluding study therapy.
Hepatic insufficiency resulting in clinical jaundice and/or coagulationdefects.
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition.The need to exclude patients with AIDS from this protocol is necessary becausethe treatments involved in this protocol may be significantlyimmunosuppressive.
Major medical illnesses or psychiatric impairments that, in the investigator'sopinion, will prevent administration or completion of protocol therapy.
Study Design
Study Description
Connect with a study center
University of Florida Health Shands Hospital
Gainesville, Florida 32610
United StatesActive - Recruiting
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