SF1126 for Patients With Relapsed or Refractory Neuroblastoma

Status: Recruiting
Phase: Phase 1
DFCI Protocol ID: 15-243

SF1126 is a novel inhibitor of PI3 kinase and mTOR that includes an active moiety (consisting of LY294002) linked to an RGDS tetrapeptide that targets the active agent to integrin expressing tissues. In this first pediatric phase 1 trial of SF1126, dose escalation will follow a 3+3 dose escalation design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 10 patients with tumors with MYCN amplification, Mycn expression, or Myc expression will be treated.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Suzanne Shusterman, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  -  Patients must have a diagnosis of neuroblastoma either by histologic verification of
     neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased
     urinary catecholamines.

  -  Patients must have high-risk neuroblastoma according to COG risk classification at
     the time of study enrollment.

  -  Patients must have at least ONE of the following: 1) Recurrent/progressive disease at
     any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease

  -  Patients must have at least ONE of the following: 1) Bone disease, 2) Any amount of
     neuroblastoma tumor cells in the bone marrow, 3) At least one soft tissue lesion that
     meets criteria for a TARGET lesion.

  -  Patients must have a Lansky (< 16 years) or Karnofsky (> 16 years) score of at least
     50

  -  Patients must have fully recovered from the acute toxic effects of all prior
     chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

  -  Patients must not be receiving any other anti-cancer agents or radiotherapy at the
     time of study entry or while on study.

  -  Patients must not be receiving other investigational medications (covered under
     another IND) within 30 days of study entry or while on study.

  -  Patients must not be receiving chronic systemic corticosteroids at doses greater than
     physiologic dosing (inhaled corticosteroids acceptable).

  -  Patient must meet the organ function requirements as stated in the protocol.

Exclusion Criteria:

  -  Pregnancy, breast feeding, or unwillingness to use effective contraception during the
     study.

  -  Patients status post-allogeneic stem cell transplant are not eligible.

  -  Patients who, in the opinion of the investigator, may not be able to comply with the
     safety monitoring requirements of the study.

  -  Patients with disease of any major organ system that would compromise their ability
     to withstand therapy.

  -  Patients who are on hemodialysis.

  -  Patients with an active or uncontrolled infection.

  -  Patients with known intraparenchymal brain metastasis at study entry are excluded due
     to poor CNS penetration of SF1126.

  -  Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
     hepatitis C.

  -  Patient declines participation in NANT 2004-05, the NANT Biology Study.

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