MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
Study of the TEM-1 Antibody, MORAb-004 (IND# 103821), in Children With Recurrent or Refractory Solid Tumors
3 other identifiers
interventional
27
1 country
20
Brief Summary
This phase I trial studies the side effects and best dose of MORAb-004 in treating young patients with recurrent or refractory solid tumors or lymphoma. Monoclonal antibodies, such as MORAb-004, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2013
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJanuary 8, 2016
December 1, 2015
1.5 years
December 11, 2012
January 7, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
MTD, defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicities (DLT) graded according to the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Up to 4 weeks
Incidence of toxicities, graded according to NCI CTCAE version 4.0
A descriptive summary of all toxicities will be reported.
Up to 3 years
Study Arms (1)
Treatment (MORAb-004)
EXPERIMENTALPatients receive anti-endosialin/TEM1 monoclonal antibody MORAb-004 IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients with relapsed or refractory solid tumors or lymphoma, excluding central nervous system (CNS) tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse; (patients with primary CNS tumors, known CNS metastases, or a prior history of CNS metastases are not eligible)
- Patients must have either measurable or evaluable disease
- Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age; Note: patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
- At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
- At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
- At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
- At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
- At least 3 half-lives of the antibody after the last dose of a monoclonal antibody
- At least 14 days after local palliative radiotherapy (XRT) (small port); at least 150 days must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if \>= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation
- No evidence of active graft vs. host disease and at least 56 days must have elapsed after transplant or stem cell infusion
- For patients with solid tumors without known bone marrow involvement:
- Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3
- Platelet count \>= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
- +18 more criteria
You may not qualify if:
- Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients receiving chronic systemic corticosteroids are not eligible
- Patients who are currently receiving another investigation drug are not eligible
- Patients who are currently receiving other anti-cancer agents are not eligible
- Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
- Patients who have known human immunodeficiency virus (HIV), viral hepatitis, or an uncontrolled infection are not eligible
- Patients with primary CNS tumors are excluded
- Patients with prior history of or known metastatic CNS disease involvement are excluded; (Note: CNS imaging for patients without a known history of CNS disease is only required if clinically indicated)
- Patients who have had or are planning to have the following invasive procedures are not eligible:
- Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment
- Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g. Hickman or Broviac) and at least 7 days prior to enrollment for subcutaneous port
- Core biopsy within 7 days prior to enrollment
- Fine needle aspirate within 7 days prior to enrollment
- Patients who have received prior solid organ transplantation 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 are not eligible
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morphoteklead
- National Cancer Institute (NCI)collaborator
- Children's Oncology Groupcollaborator
Study Sites (20)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
University of California San Francisco Medical Center - Parnassus
San Francisco, California, 94143, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20310, United States
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, 30307, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 18150, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
University of Minnesota Cancer Center-Fairview
Minneapolis, Minnesota, 55435, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Norris RE, Fox E, Reid JM, Ralya A, Liu XW, Minard C, Weigel BJ. Phase 1 trial of ontuxizumab (MORAb-004) in children with relapsed or refractory solid tumors: A report from the Children's Oncology Group Phase 1 Pilot Consortium (ADVL1213). Pediatr Blood Cancer. 2018 May;65(5):e26944. doi: 10.1002/pbc.26944. Epub 2018 Jan 2.
PMID: 29292843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin Norris
Children's Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2012
First Posted
December 12, 2012
Study Start
November 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
January 8, 2016
Record last verified: 2015-12