At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 13 enrolled

Drug / intervention

Irinotecan +3 moredrug

Likely dose

Irinotecan 30 mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00993044

NCT00993044Phase 1Completed

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A Phase I 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

Children's Hospital Los Angeles·interventional·Posted Oct 9, 2009·Updated Oct 6, 2023

In Brief

A Phase 1 clinical trial evaluating Irinotecan, Vincristine, and 2 other interventions for Refractory Solid Tumors in Children. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This phase I study is designed to determine the maximum tolerated dose of Irinotecan given intravenous for 5 days every 3 weeks in combination with fixed doses of Vincristine, Temozolomide and Bevacizumab (VIT-B) in patients with refractory solid tumors.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRefractory Solid Tumors in Children

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartSep 2009

First PostedOct 2009

Primary CompletionFeb 2013

TodayJul 2026

First PostedOct 9, 2009

Enrollment StartSep 1, 2009

Primary CompletionFeb 1, 2013

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 16.7 years ago

Interventions

Irinotecandrug

Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5 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 1.5\* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5 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 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 20 mg/m2/day IV on day 1,2,3,4 and 5 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 escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed on dose level 2

Vincristinedrug

Temozolomidedrug

Bevacizumabdrug