Adoptive cellular therapy for recurrent oligodendroglioma in adults
ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients
This study is testing a new treatment that combines immune therapy and specific drugs to see if it can help adults with recurring oligodendroglioma feel better and improve their outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | radiation, chemotherapy, immunotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06254326 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in adult patients with recurrent or progressive oligodendroglioma. Participants will undergo surgery or biopsy for diagnosis and tumor material collection, followed by a series of treatments including chemotherapy and dendritic cell vaccines. The treatment regimen involves mobilizing peripheral blood mononuclear cells (PBMCs) and generating tumor RNA-pulsed dendritic cells (TTRNA-DCs) to enhance the immune response against the tumor. The study aims to assess the effectiveness of this combined approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with recurrent or progressive IDH-mutant oligodendroglioma WHO grade 2 or 3.
Not a fit: Patients with non-IDH-mutant oligodendroglioma or those who are not candidates for surgery or biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel immunotherapy option for patients with recurrent oligodendroglioma, potentially improving survival rates.
How similar studies have performed: While this approach is innovative, similar studies using immunotherapy in brain tumors have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Oligodendroglioma WHO 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 ≥ 60 mL/min for patients with serum creatinine \> 1.5 x IULN * Serum total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total 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 use acceptable contraceptive methods 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 disease free for ≥ 3 years. * Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal 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 or infant. * Treatment with another investigational drug or other intervention within 30 days prior 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 time of enrollment. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy. * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the 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.
Where this trial is running
Gainesville, Florida
- University of Florida Health Shands Hospital — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Ashley Ghiaseddin, MD — University of Florida
- Study coordinator: Phuong Deleyrolle, RN
- Email: phuong.deleyrolle@neurosurgery.ufl.edu
- Phone: 352-273-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.