PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy

  • STATUS
    Recruiting
  • End date
    Sep 9, 2030
  • participants needed
    24
  • sponsor
    Giselle SaulnierSholler
Updated on 10 October 2021
cancer
depo-provera
filgrastim
granulocyte colony stimulating factor
bone marrow procedure
colony stimulating factor
neutrophil count

Summary

A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs) (TTRNA-DCs), Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) and Autologous G-CSF mobilized Hematopoietic Stem Cells (HSCs)).

Details
Condition Neuroblastoma, Diffuse Intrinsic Pontine Glioma, DIPG, neuroblastomas
Treatment Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
Clinical Study IdentifierNCT04837547
SponsorGiselle SaulnierSholler
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies fitting into one of the following categories
Disease Status
High Risk Neuroblastoma-
Patients that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive/progressive to accepted curative chemotherapy
Neuroblastoma must be age >12 months at enrollment
Diffuse Intrinsic Pontine (or other brain stem) Glioma
Newly-diagnosed patients willing to undergo biopsy
Must be within 2 months of diagnosis and prior to starting radiation
DIPG must be 3 years of age at enrollment
All subjects must be age 30 years at enrollment
Patient and/or parents/guardian willing to consent to biopsy for obtaining tumor material for confirmatory diagnosis and/or tumor RNA extraction and amplification
Subjects must have measurable disease as defined Per section 8 at the time of biopsy and tumor must be accessible for biopsy. Tumor samples submitted for analysis must contain >30% viable tumor tissue to qualify. In addition, subjects with NB disease confined to the bone marrow are eligible to enroll if the degree of marrow involvement is expected to be >30%
Current disease state must be one for which there is currently no known effective therapy
Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing
Lansky or Karnofsky Score must be 60
Bone Marrow
ANC (Absolute neutrophil count) 1000/l (unsupported)
Platelets 100,000/l (can be transfused)
Hemoglobin > 8 g/dL (can be transfused)
Renal: Serum creatinine upper limit of institutional normal
Adequate liver function must be demonstrated, defined as
Total bilirubin 1.5 x upper limit of normal (ULN) for age AND
ALT (SGPT) 3 times upper limit of normal (ULN) for age
AST (SGOT) 3 times upper limit of normal (ULN) for age
Subjects with CNS disease currently taking steroids must have been on a stable dose of steroids for at least one week prior to their biopsy and must not have progressive hydrocephalus at enrollment
A negative serum pregnancy test is required for female participants of childbearing potential (13 years of age or after onset of menses)
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended
Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
Post-Biopsy: Patients with post-biopsy neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration

Exclusion Criteria

Absence of tumor on biopsy specimen or a diagnosis other than NBL or glioma on biopsy
Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection
Subjects with significant renal, cardiac, pulmonary, hepatic or other organ dysfunction
Prior allergic reaction to GM-CSF or Td
Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to biopsy or focal radiotherapy in the case of patients with diffuse intrinsic pontine (or other brain stem) gliomas
Subjects with NBL who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy)
Subjects receiving any investigational drug concurrently
Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor)
Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study
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