SF1126 for Patients With Relapsed or Refractory Neuroblastoma



Status:Terminated
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 30
Updated:8/22/2018
Start Date:July 9, 2015
End Date:May 22, 2018

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Phase I Study of SF1126 for Patients With Relapsed or Refractory Neuroblastoma

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

Inhibitors of the PI3 kinase pathway have demonstrated preclinical activity in neuroblastoma.
This activity may derive in part from destabilizing Mycn protein, impeding tumor
angiogenesis, and/or other effects. 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 preclinical studies, SF1126
results in marked concentration of LY294002 into tumors. In an adult phase 1 trial, a maximum
tolerated dose of SF1126 was not identified up to doses of 1110 mg/m2 administered
intravenously twice weekly on a continuous schedule. 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. All patients will
participate in mandatory pharmacokinetic testing. Additional optional correlative studies
will evaluate potential predictive markers and potential pharmacodynamic markers, including
PTEN and PIK3CA aberrations, Myc / Mycn expression, and Myc / pS6 levels in peripheral blood
mononuclear cells.

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.
We found this trial at
11
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-9863
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
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1405 Clifton Road Northeast
Atlanta, Georgia 30322
(404) 785-6000
Phone: 404-785-0853
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus...
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Boston, Massachusetts 02115
Phone: 617-632-3725
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5721 S. Maryland Avenue
Chicago, Illinois 60637
Phone: 773-843-3943
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 323-361-5687
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
Phone: 415-476-3831
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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Aurora, Colorado 80045
Phone: 720-777-8856
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Fort Worth, Texas 76104
Phone: 682-885-4007
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Seattle, Washington 98105
Phone: 206-987-5783
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