Trial Outcomes & Findings for A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin (NCT NCT00993044)

NCT ID: NCT00993044

Last Updated: 2023-10-06

Results Overview

Number of participants with dose limiting toxicity events

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2023-10-06

Participant Flow

Participant milestones

Measure	Single Arm combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1 Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level 1.5\* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5 \* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed
Irinotecan 30 mg STARTED	6
Irinotecan 30 mg COMPLETED	6
Irinotecan 30 mg NOT COMPLETED	0
Irinotecan 50 mg STARTED	7
Irinotecan 50 mg COMPLETED	6
Irinotecan 50 mg NOT COMPLETED	1

Reasons for withdrawal

Measure

Single Arm combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1 Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level 1.5\* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5 \* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed

Irinotecan 50 mg Physician Decision

1

Baseline Characteristics

A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin

Baseline characteristics by cohort

Measure	Dose Level 1, 2 n=12 Participants
Age, Continuous	11 Years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Number of participants with dose limiting toxicity events

Outcome measures

Measure

Single Arm n=12 Participants combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1 Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level 1.5\* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5 Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5 \* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed

Dose Limiting Toxicity

2 participants

Adverse Events

Dose Level 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Level 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Level 1 n=6 participants at risk combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1 Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5	Dose Level 2 n=6 participants at risk combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1 Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5
Hepatobiliary disorders Hyperbilirubinemia	16.7% 1/6 • Number of events 1	0.00% 0/6
Gastrointestinal disorders colitis	0.00% 0/6	16.7% 1/6 • Number of events 1

Other adverse events

Measure	Dose Level 1 n=6 participants at risk combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1 Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5	Dose Level 2 n=6 participants at risk combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1 Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5
Blood and lymphatic system disorders Anemia	100.0% 6/6	100.0% 6/6
Blood and lymphatic system disorders Thrombocytopenia	100.0% 6/6	100.0% 6/6
Blood and lymphatic system disorders Neutropenia	100.0% 6/6	100.0% 6/6

Additional Information

Rajkumar Venkatramani

Children's Hospital Los Angeles

Phone: 3233615504

Email: rvenkatramani@chla.usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place