Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 53
Summary
- Conditions
- Recurrent Lymphoma
- Recurrent Malignant Solid Neoplasm
- Recurrent Primary Central Nervous System Neoplasm
- Refractory Lymphoma
- Refractory Malignant Solid Neoplasm
- Refractory Primary Central Nervous System Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 621 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of pevonedistat administered as an intravenous infusion on days 1, 8, 10, and 12 of a 28-day cycle (cycle 1), and on days 1, 3, and 5 of a 21-day cycle (cycle 2 and beyond) in combination with ...
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of pevonedistat administered as an intravenous infusion on days 1, 8, 10, and 12 of a 28-day cycle (cycle 1), and on days 1, 3, and 5 of a 21-day cycle (cycle 2 and beyond) in combination with irinotecan (administered as an intravenous infusion on days 8-12 of cycle 1 and days 1-5 of cycles 2+) and temozolomide (administered orally on days 8-12 in cycle 1 and days 1-5 of cycles 2+) in children with recurrent or refractory solid tumors, including central nervous system (CNS) tumors and lymphoma. II. To define and describe the toxicities of pevonedistat administered on this schedule. III. To characterize the pharmacokinetics of pevonedistat in children with recurrent or refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of pevonedistat within the confines of a phase 1 study. II. To assess the biologic activity of pevonedistat. OUTLINE: This is a dose escalation study of pevonedistat. Patients receive pevonedistat intravenously (IV) over 60 minutes on days 1, 8, 10, and 12, temozolomide orally (PO) daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Tracking Information
- NCT #
- NCT03323034
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jennifer H Foster Pediatric Early Phase Clinical Trial Network