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Protocol No. APEC1621D

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

Title NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)-Phase 2 Subprotocol of LY3023414 in Patients with Solid Tumors

Objective
Phase 2 study of a drug called LY3023414. In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on tumors.
We are using LY3023414 in this study because it was shown to block the growth of cancer cells with mutations in an important cell-signaling pathway (called the PI3K/MTOR pathway) in test tubes and in animals. Genes in this pathway are frequently mutated in many types of cancers. To be eligible for this study tumors have to have a mutation in one of these genes.
Although LY3023414 has been given to a small number of adults, we do not know if it will work against this type of tumor.
A Phase 1 study of LY3023414 to find the highest dose of an experimental drug that can be given without too many side effects has been completed in adults with cancer. This study will be the first time that LY3023414 is given to children and adolescents.
The dose for the first group of children and adolescents enrolled on the study will be based on the side effects seen in adults. Between 2 and 6 children and adolescents will receive LY3023414 at this dose. If the side effects are not too severe, the next group of children and adolescents will receive a higher dose. If there are too many side effects, the next group of children and adolescents will receive a lower dose. Dosing is done this way because we do not yet know the best dose to use in children and adolescents. Enrollment early in this study patients may receive a lower or higher dose than those who are enrolled later. A higher dose may be more likely to cause side effects. A lower dose may be less likely to have any effect on tumors.

Treatment LY3023414 will be given by mouth twice a day for 28 days, for up to 2 years unless development of serious side effects or tumor worsens.

Description Phase 2, Pediatric MATCH sub protocol of LY3023414 for treatment of solid tumors

Key Eligibility
  • Must be ≥ than 12 months and ≤ 21 years of age
  • Dose Level 1 must have a body surface area ≥ 0.52 m2
  • Dose Level 2 must have a body surface area ≥ 0.37 m2
  • Dose Level -1 must have a body surface area ≥ 0.75 m2
  • Must have radiographically measurable disease
  • Neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible
  • Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
  • Must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
  • Must not have received prior exposure to LY3023414
  • Must not have received prior exposure to an agent specifically directed at the PI3K/MTOR pathway (a PI3K inhibitor, an AKT inhibitor, an MTOR inhibitor, including rapalogs, or a combined PI3K/MTOR inhibitor).
  • Must have adequate bone marrow, liver, renal, neurological, and cardiac function.
  • Must have normal blood sugars for age.
  • Patients who have insulin dependent diabetes are not eligible.
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients with SubEpendymal Giant cell Astrocytomas (SEGAs) are not eligible
  • Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
  • ≥ 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
  • ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1
  • If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid
  • ≥ 14 days after the last dose of a longacting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor
  • ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
  • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion: ≥ 84 days after infusion and no evidence of GVHD
  • Autologous stem cell infusion including boost infusion: ≥ 42 days
  • ≥ 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
  • ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial BM radiation
  • ≥ 42 days after systemically administered radiopharmaceutical therapy

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open (affiliates only)

    Participating Institutions Gundersen Health System