TerminatedPhase 1

Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)

Stopped: Not feasible to accrue due to competing studies

United States11 participantsStarted 2018-07-17

Plain-language summary

The standard of care for children with DIPG includes focal radiotherapy (RT) but outcomes have remained dismal despite this treatment. The addition of oral Temozolomide (TMZ) concurrently with RT followed by monthly TMZ was also found to be safe but ineffective. Recent studies in adults have shown that certain types of chemotherapy induce a profound but transient lymphopenia (low blood lymphocytes) and vaccinating and/or the adoptive transfer of tumor-specific lymphocytes into the cancer patient during this lymphopenic state leads to dramatic T cell expansion and potent immunologic and clinical responses. Therefore, patients in this study will either receive concurrent TMZ during RT and immunotherapy during and after maintenance cycles of dose-intensive TMZ (Group A) or focal radiotherapy alone and immunotherapy without maintenance DI TMZ (Group B). Immune responses during cycles of DC vaccination with or without DI TMZ will be evaluated in both treatment groups.

Who can participate

Age range3 Years – 30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Initial Screening * Radiologically confirmed DIPG or other diffuse intrinsic brain stem glioma (Grade III or IV). * Patient and/or parents/guardian willing to consent to biopsy for obtaining tumor material for confirmatory diagnosis and/or tumor RNA extraction and amplification. * Biopsy confirmation of any grade of glioma (for patients with classic DIPG on neuroimaging or at least grade III glioma in case of other diffuse intrinsic brain stem gliomas) * Karnofsky Performance Status (KPS) of \> 50% (KPS for \> 16 years of age) or Lansky performance Score (LPS) of ≥ 50 (LPS for ≤ 16 years of age) assessed within 2 weeks prior to registration; * Bone Marrow; * ANC (absolute neutrophil count) ≥ 1000/µl (unsupported) * Platelets ≥ 100,000/µl (unsupported) * Hemoglobin \> 8 g/dL (can be transfused) * Renal; * Serum creatinine ≤ upper limit of institutional normal * Hepatic; * Bilirubin ≤ 1.5 times upper limit of institutional normal for age * SGPT (ALT) ≤ 3 times upper limit of institutional normal for age * SGOT (AST) ≤ 3 times upper limit of institutional normal for age * Patients of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control while being treated on this study. * Signed informed consent according to institutional guidelines. Post Biopsy * Patients with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration; * Pathologic diagnosi…

What they're measuring

Feasibility and safety of adoptive cellular therapy in pediatric patients with DIPG with or without dose-intensified TMZ during cycles of DC vaccination

Timeframe: From first DC Vaccine through 30 days after administration of the last dose of trial drug or subject death

Determine the maximally achievable dose (MAD) or maximum tolerated dose (MTD) of xALT plus DC and HSC in Group A and Group B subjects

Timeframe: From first DC vaccine in Group A until 14 days after administration of the last dose of investigational product is given.

Trial details

NCT IDNCT03396575

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-20

View on ClinicalTrials.gov More Diffuse Intrinsic Pontine Glioma (DIPG) trials