SF1126 for Patients With Relapsed or Refractory Neuroblastoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02337309 |
Recruitment Status :
Terminated
(Low patient accrual)
First Posted : January 13, 2015
Last Update Posted : August 20, 2018
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroblastoma | Drug: SF1126 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of SF1126 for Patients With Relapsed or Refractory Neuroblastoma |
Actual Study Start Date : | July 9, 2015 |
Actual Primary Completion Date : | May 22, 2018 |
Actual Study Completion Date : | May 22, 2018 |

Arm | Intervention/treatment |
---|---|
SF1126
Patients will receive SF1126 IV over 90 minutes on Days 1 and 4 of each week during each cycle.
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Drug: SF1126
SF1126 in IV form with be given to patients on this study. |
- Toxicities, based on the CTCAE criteria, will be used to measure the severity of adverse events [ Time Frame: 6 months ]Toxicity will be graded using the CTCAE criteria, version 4. The CTCAE provides descriptive terminology and a grading scale for each adverse event listed. A copy of the CTCAE can be downloaded from the CTEP home page (http://ctep.cancer.gov).
- Evaluation of response [ Time Frame: After day 1 of week 4 of cycles 2, 4, and 6 ]Response will be determined by the evaluation of CT/MRI scans and bone marrow biopsy.
- Pharmacokinetics: Parameters include AUC, clearance, Cmax, Tmax, & terminal half-life for SF1101 & SF1174. With rapid conversion of SF1126 to SF1101, only AUC, clearance, Cmax & Tmax are calculated for SF1126. [ Time Frame: Day 1, cycle 1 ]Plasma samples will be collected from patients at 9 time points on Day 1 of the first cycle.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337309
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027-0700 | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
Children Hospital of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Georgia | |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
University of Chicago Comer Children's Hospital | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Childrens Hospital Boston, Dana-Farber Cancer Institute. | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
C.S Mott Children's Hospital | |
Ann Arbor, Michigan, United States, 48109 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Texas | |
Cook Children's Healthcare System | |
Fort Worth, Texas, United States, 76104 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States, 98105 |
Principal Investigator: | Steven DuBois, MD | Dana-Farber Cancer Institute |
Responsible Party: | New Approaches to Neuroblastoma Therapy Consortium |
ClinicalTrials.gov Identifier: | NCT02337309 |
Other Study ID Numbers: |
NANT 2014-01 N14-01 ( Other Identifier: NANT Consortium ) R01FD005740 ( U.S. FDA Grant/Contract ) |
First Posted: | January 13, 2015 Key Record Dates |
Last Update Posted: | August 20, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |