Spots Global Cancer Trial Database for Pomalidomide in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
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Trial Identification
Brief Title: Pomalidomide in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
Official Title: A Phase I Trial of Pomalidomide for Children With Recurrent, Progressive, or Refractory CNS Tumors
Study ID: NCT02415153
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of pomalidomide in treating younger patients with tumors of the brain or spine (central nervous system) that have come back or are continuing to grow. Pomalidomide may interfere with the ability of tumor cells to grow and spread and may also stimulate the immune system to kill tumor cells.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of pomalidomide, in children from \>= 3 years to \< 21 years of age with recurrent, progressive or refractory central nervous system (CNS) tumors when given once daily for 21 consecutive days of a 28-day course. II. To describe the toxicity profile and dose-limiting toxicities of pomalidomide in children from \>= 3 years to \< 21 years of age with recurrent, progressive or refractory CNS tumors. III. To characterize the pharmacokinetics of pomalidomide when administered orally in children from \>= 3 years old to \< 21 years of age with recurrent, progressive or refractory CNS tumors and study the association of pharmacokinetic (PK) parameters with age and steroid use. SECONDARY OBJECTIVES: I. To explore the preliminary efficacy of pomalidomide in this patient population as defined by radiographic response rate, duration of response, and event-free survival (EFS) within the confines of a Phase 1 study. \*For the purposes of this study, long-term stable disease will be considered a response (defined as stable disease for \>= 6 courses). II. To investigate a relationship between pomalidomide dose and exposure with radiographic response and changes in immune function (for example, T-cell subsets, natural killer \[NK\] cell activity, granzyme B and circulating levels of IL-12, IL-2, IL-15, GM-CSF). OUTLINE: This is a dose-escalation study. Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
Keywords
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
National Cancer Institute, Rockville, Maryland, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Texas Children's Hospital, Houston, Texas, United States
Contact Details
Name: Jason R Fangusaro
Affiliation: Pediatric Brain Tumor Consortium
Role: PRINCIPAL_INVESTIGATOR
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