SF1126 for Patients With Relapsed or Refractory Neuroblastoma

Stopped early · Phase 1

Conditions studied: Neuroblastoma

In brief

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. Funding Source - FDA OOPD

Key facts

Study ID

NCT02337309

Run by

New Approaches to Neuroblastoma Therapy Consortium

People needed

4

Starts

2015-07-09

Expected to finish

2018-05-22

Last updated by the study team

2018-08-20

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Children Hospital of Colorado — Aurora, Colorado, United States
• AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus — Atlanta, Georgia, United States
• University of Chicago Comer Children's Hospital — Chicago, Illinois, United States
• Childrens Hospital Boston, Dana-Farber Cancer Institute. — Boston, Massachusetts, United States
• C.S Mott Children's Hospital — Ann Arbor, Michigan, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cook Children's Healthcare System — Fort Worth, Texas, United States
• Children's Hospital and Regional Medical Center - Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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