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New treatment option for Ependymoma
Official title Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
ClinicalTrials.gov ID: NCT05106296
What this study is testing
What is Indoximod?
Indoximod is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ependymoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 25
You may be able to join if
- Diagnosis:
- Patients must have prior documented progressive or refractory disease with histologically proven initial diagnosis of ependymoma, medulloblastoma...
- Metastatic disease is acceptable.
- Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease. Patients must be able to swallow pills. Lansky...
- Creatinine clearance (CLcr) \> 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient...
You likely can't join if
- Patients who are unable to swallow pills. Patients with known hypersensitivity to any drugs in the treatment plan. Patients with active autoimmune...
- Allergies, allergic conditions, and reactive inflammatory conditions that are not autoimmune in nature would not exclude patients (e.g., eczema...
See the full eligibility criteria
- Diagnosis:
- Patients must have prior documented progressive or refractory disease with histologically proven initial diagnosis of ependymoma, medulloblastoma, glioblastoma, or another type of primary cancer of the central nervous...
- Metastatic disease is acceptable.
- Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease. Patients must be able to swallow pills. Lansky or Karnofsky performance status score must be ≥ 50%. Adequate renal...
- Creatinine clearance (CLcr) \> 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient. Adequate liver function:
- Alanine aminotransferase (ALT) ≤ 3-times upper limit of normal.
- Aspartate aminotransferase (AST) ≤ 3-times upper limit of normal.
- Total bilirubin ≤ 1.5-times upper limit of normal unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin. Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1000/mm3 (independent of growth factor support).
- Platelets ≥ 100,000/mm3 (independent of transfusion support).
- Hemoglobin ≥ 8 g/dL (independent of transfusion support). Seizure disorders must be well controlled on antiepileptic medication. Prior therapy:
- Patients previously treated with chemotherapy drugs included in this protocol are eligible for enrollment.
- At the time of Screening, patients must be at least 21 days from the administration of any investigational agent (other than indoximod) or prior cytotoxic therapy (including chemotherapy).
- At the time of Screening, patients must be at least 28 days from administration of antibody-based therapies (e.g., bevacizumab), tumor-directed vaccines, or cellular immune therapies (e.g., T cells, NK cells, etc.).
- At the time of Screening, patients must be at least 56 days from administration of tumor-directed therapies using infectious agents (e.g., viruses, bacteria, etc.).
- At the time of Screening, patients must be at least 90 days from any radiation or proton therapy (all modalities, including radiosurgery) that targeted all sites of known disease.
- There is no lock-out window for patients who were treated with focal radiation or focal proton therapy (all modalities, including radiosurgery) that did not target all disease sites, if at least one site of active tumor...
- No investigational or commercial agents, including intrathecal drugs, other than that described by this clinical study protocol (GCC2020) may be administered with the intent to treat the patient's malignancy while they...
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study. Men must agree to not donate sperm during and for 3 months after...
- Women who are pregnant or breastfeeding are ineligible for this study.
- Patients who become pregnant while participating in this study will have to stop Study Therapy. Patients, or their parent for patients less than 18 years of age, must sign an Informed Consent Document indicating that...
- Patients who are unable to swallow pills. Patients with known hypersensitivity to any drugs in the treatment plan. Patients with active autoimmune disease that requires systemic therapy.
- Allergies, allergic conditions, and reactive inflammatory conditions that are not autoimmune in nature would not exclude patients (e.g., eczema, asthma, etc.). Pregnant or breastfeeding women. Major surgery or a wound...
The study team makes the final eligibility decision.
Where it's taking place
- Augusta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augusta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.