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History of Changes for Study: NCT02337309
SF1126 for Patients With Relapsed or Refractory Neuroblastoma
Latest version (submitted August 16, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 8, 2015 None (earliest Version on record)
2 July 14, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 August 14, 2015 Contacts/Locations and Study Status
4 December 11, 2015 Study Status, IPDSharing, Contacts/Locations and Oversight
5 December 18, 2015 Recruitment Status, Contacts/Locations and Study Status
6 March 21, 2017 Study Status
7 August 11, 2017 Study Status and Contacts/Locations
8 August 14, 2017 Recruitment Status, Contacts/Locations and Study Status
9 September 1, 2017 Study Status, Contacts/Locations, Study Description and Study Identification
10 November 2, 2017 Study Status and Contacts/Locations
11 January 17, 2018 Contacts/Locations and Study Status
12 May 30, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
13 August 16, 2018 Study Status and Contacts/Locations
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Study NCT02337309
Submitted Date:  January 8, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: NANT 2014-01
Brief Title: SF1126 for Patients With Relapsed or Refractory Neuroblastoma
Official Title: Phase I Study of SF1126 for Patients With Relapsed or Refractory Neuroblastoma
Secondary IDs: N14-01 [NANT Consortium]
Open or close this module Study Status
Record Verification: January 2015
Overall Status: Not yet recruiting
Study Start: January 2015
Primary Completion: December 2017 [Anticipated]
Study Completion: June 2018 [Anticipated]
First Submitted: December 18, 2014
First Submitted that
Met QC Criteria:
January 8, 2015
First Posted: January 13, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 8, 2015
Last Update Posted: January 13, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: New Approaches to Neuroblastoma Therapy Consortium
Responsible Party: Sponsor
Collaborators: SignalRX Pharmaceuticals, Inc.
University of Southern California
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description: 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.
Open or close this module Conditions
Conditions: Neuroblastoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 28 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
SF1126
Patients will receive SF1126 IV over 90 minutes on Days 1 and 4 of each week during each cycle.
Drug: SF1126
SF1126 in IV form with be given to patients on this study.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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).
Secondary Outcome Measures:
1. 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.
2. 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.
Open or close this module Eligibility
Minimum Age: 1 Year
Maximum Age: 30 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Araz Marachelian, MD
Telephone: 323-361-8573
Email: amarachelian@chla.usc.edu
Study Officials: Steven DuBois, MD
Principal Investigator
UCSF School of Medicine
Locations: United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Lucille Salter Packer Children's Hospital, Stanford University
Palo Alto, California, United States, 94305
Contact:Contact: Claire - Twist, MD 650-723-5535 claire.twist@stanford.edu
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Contact:Contact: Katherine K. Matthay, MD 415-476-3831 matthayK@peds.ucsf.edu
United States, Colorado
Children Hospital of Colorado
Aurora, Colorado, United States, 80045
Contact:Contact: Margaret Macy, MD 720-777-8856 Margaret.macy@childrenscolorado.org
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
Contact:Contact: Kelly Goldsmith, MD 404-785-0853 kgoldsm@emory.edu
United States, Illinois
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States, 60637
Contact:Contact: Susan L. Cohn, MD 773-702-2571 scohn@peds.bsd.uchicago.edu
United States, Massachusetts
Childrens Hospital Boston, Dana-Farber Cancer Institute.
Boston, Massachusetts, United States, 02115
Contact:Contact: Suzanne - Shusterman, MD 617-632-3725 suzanne_shusterman@dfci.harvard.edu
United States, Michigan
C.S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Contact:Contact: Gregory Yanik, MD 734-936-8785 gyanik@umich.edu
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Contact:Contact: Stephen Roberts, MD 212-639-4034 robertss@mskcc.org
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
United States, Texas
Cook Children's Healthcare System
Fort Worth, Texas, United States, 76104
Contact:Contact: Meaghan Granger, MD 682-885-4007 mgranger@cookchildrens.org
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Contact:Contact: Julie R. Park, MD 206-987-1947 Julie.park@seattlechildrens.org
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Contact:Contact: Sylvain Baruchel, MD 416-813-7795 sylvain.baruchel@sickkids.ca
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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