Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy During Recover From Myeloablative Chemotherapy and Hematopoietic Stem Cell Transplantation

Who is this study for? Patients with Medulloblastoma, Neuroectodermal Tumor
Status: Completed
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Immunotherapy is a specific approach to treating cancer that has shown promise in adult patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study investigators will use the experience they have gained from these studies to try to improve the outcome for children affected by a recurrent brain tumor. Approximately 35 patients with first recurrence of medulloblastoma (reMB)/supratentorial primitive neuroectodermal tumors (PNETs) will be treated with tumor-specific immune cells and dendritic cell vaccines to see what impact they have on the tumor.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 30
Healthy Volunteers: f
View:

⁃ Screening:

• Age ≤ 30 years of age.

• Suspected first recurrence/progression of MB/PNET since completion of definitive focal +/- craniospinal irradiation. Disease progression prior to receiving definitive focal +/- craniospinal irradiation will not disqualify patients from enrollment if they have subsequently failed definitive radiotherapy and are at first recurrence/progression at time of enrollment. Patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation) are eligible for enrollment at first disease recurrence/progression.

⁃ Re-MATCH Protocol:

• Patients must have histologically confirmed recurrent MB/PNET that is a first relapse/progression after completion of definitive radiotherapy +/- craniospinal irradiation. Patients with a first relapse/progression who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (ie. Gorlin's syndrome or NF1 mutation) are eligible for enrollment.

• Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.

• Karnofsky Performance Status of ≥ 50% or Lansky Performance Score of ≥ 50.

• Absolute Neutrophil Count (ANC) ≥ 1000/µl (unsupported).

• Platelets ≥ 100,000/µl (unsupported).

• Hemoglobin \> 8 g/dL (may be supported).

• Serum creatinine ≤ upper limit of institutional normal

• Bilirubin ≤ 1.5 times upper limit of normal for age.

• Serum Glutamic Oxaloacetic Transaminase (ALT) ≤ 3 times institutional upper limit of normal for age.

• Serum Glutamic Oxaloacetic Transaminase (AST) ≤ 3 times institutional upper limit of normal for age.

• Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.

• Patient or patient guardian consent to peripheral blood stem cell (PBSC) and/or bone marrow harvest following registration if PBSC or bone marrow (CD34 count of at least 2x10\^6/kg) has not been previously stored and available for use.

• Signed informed consent according to institutional guidelines must be obtained prior to registration.

Locations
United States
California
Children's Hospital Los Angeles
Los Angeles
Washington, D.c.
Children's National Medical Center
Washington D.c.
Florida
University of Florida
Gainesville
Time Frame
Start Date: 2010-09-07
Completion Date: 2025-03-28
Participants
Target number of participants: 26
Treatments
Experimental: Group A
High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.
Experimental: Group B
NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.
Sponsors
Collaborators: United States Department of Defense
Leads: University of Florida

This content was sourced from clinicaltrials.gov

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