NCT02358187 A Vaccine Trial for Low Grade Gliomas
| NCT ID | NCT02358187 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | James Felker |
| Condition | Low Grade Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2015-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2015-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will assess the immunogenicity, safety and preliminary clinical efficacy of the glioma associated antigen (GAA)/tetanus toxoid (TT) peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.
Eligibility Criteria
Inclusion Criteria: Tumor Type * Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as a biologic regimen. Patients may not have received radiation therapy to the index lesion within 1 year of enrollment. Patients may have tumor spread within the central nervous system (CNS). * HLA-A2 positive based on flow cytometry. * Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study registration. * Patients must be ≥ 12 months and \< 22 years of age at the time of HLA-A2 screening. * Patients must have a performance status of ≥ 70; (Karnofsky if \> 16 years and Lansky if ≤ 16 years of age. * Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal. Because the effect of the peptide-based vaccine and poly-ICLC on the fetus has not sufficiently been investigated, pregnant females will not be included in the study. * Patients must be free of systemic infection requiring IV antibiotics at the time of registration. Patients must be off IV antibiotics for at least 7 days prior to registration. * Patients with adequate organ function as measured by: Bone marrow: absolute neutrophil count (ANC) \> 1,000/µ; Platelets \> 100,000/µ (transfusion independent); absolute lymphocyte count of ≥ 500/µ; Hemoglobin \>8 g/dl (may be transfused). Hepatic: bilirubin \< 1.5x institutional normal for age; serum glutamate pyruvate transaminase (SGPT) \< 3x institutional normal. * Renal: Serum creatinine based on age or Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 ml/min/ml/min/1.73 m² * Patients must have recovered from the toxic effects of prior therapy to grade 1 or better. Patients must be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy. * No overt cardiac, gastrointestinal, pulmonary or psychiatric disease. Exclusion Criteria: * Patients living outside of North America are not eligible. * Patients may not have received radiation to the index lesion within 1 year of enrollment. * Concurrent treatment or medications (must be off for at least 1 week) including: * Interferon (e.g. Intron-A®) * Allergy desensitization injections * Growth factors (e.g. Procrit®, Aranesp®, Neulasta®) * Interleukins (e.g. Proleukin®) * Any investigational therapeutic medication * Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. * Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period must be tapered to no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone for at least one week before study registration. Topical corticosteroids are acceptable. * Because patients with immune deficiency are not expected to respond to this therapy, HIV-positive patients are excluded from the study. * Patients who have received prior immunotherapy.
Contact & Investigator
James Felker, MD
📞 412 692-5055
James Felker, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT02358187 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 21 Years, studying Low Grade Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02358187 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02358187 currently recruiting?
Yes, NCT02358187 is actively recruiting participants. Visit ClinicalTrials.gov or contact James Felker to inquire about joining.
Where is the NCT02358187 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT02358187 clinical trial?
NCT02358187 is sponsored by James Felker. The principal investigator is James Felker, MD at University of Pittsburgh. The trial plans to enroll 25 participants.