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A Pilot Study to Evaluate the Effects of Imiquimod and Tumor Lysate Vaccine Immunotherapy for Adults With High Risk or Recurrent/Post-Chemotherapy WHO Grade II Gliomas
This is a pilot study of a vaccination regime that is designed to efficiently induce anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will induce potent anti-glioma immune response with minimal or no toxicity.
Details
| Lead sponsor | Frank Lieberman |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Enrolment | 19 |
| Start date | 2012-10 |
| Completion | 2018-11-08 |
Conditions
- High Risk WHO Grade II Glioma
- Recurrent/Post-Chemotherapy WHO Grade II Glioma
Interventions
- Tumor Lysate Vaccine
- Imiquimod
Primary outcomes
- Dose limiting toxicity (DLT) — Two Years
The incidence and severity of adverse events associated with the vaccine regime will be assessed according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE), as follows: 1. . Grade 3-5 vaccine related allergic reaction 2. . Grade 3-5 organ toxicity (cardiac, dermatologic (excluding localized skin reaction), gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy and occurring within 28 days of vaccination and of any length in duration 3. . Grade 2 -5 autoimmune reactions (such as hypothyroidism) - Induction of BTIC Lysate-specific T-cell response — Two Years
We will determine the response rate and magnitude of immune response in post-vaccine peripheral blood mononuclear cells (PBMC) against the BTIC Lysate in response to this form of vaccine, using IFN-enzyme-linked immuno-spot (ELISPOT) assays.
Countries
United States