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 Angeles1 site in 1 country13 target enrollmentSeptember 2009

ConditionsRefractory Solid Tumors in Children

InterventionsIrinotecan Vincristine Temozolomide Bevacizumab

DrugsIrinotecan Vincristine Temozolomide Bevacizumab

Overview

Phase: Phase 1
Intervention: Irinotecan
Conditions: Refractory Solid Tumors in Children
Sponsor: Children's Hospital Los Angeles
Enrollment: 13
Locations: 1
Primary Endpoint: Dose Limiting Toxicity
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

February 2013

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Children's Hospital Los Angeles

Responsible Party

Principal Investigator

Leo Mascarenhas

Medical Staff/USC Faculty CWR

Children's Hospital Los Angeles

Eligibility Criteria

Inclusion Criteria

•Age: Patients must be \> 12 months and \< 21 years of age at the time of study entry.
•Weight: Patient must be more than or equal to 10 Kilograms.
•Histological Diagnosis:
•Patients must have had histological verification of the malignancy at some time prior to study entry.
•All solid tumors are eligible with the exclusion of lymphomas. For patients with neuroblastoma, diagnosis based on elevated catecholamines in the urine and tumor cells on bone marrow aspirates/biopsies is acceptable.
•For patients with germ cell tumors, diagnosis based on elevated tumor markers (serum alpha fetoprotein and/or serum beta human chorionic gonadotropin) and radiographic evidence of disease is acceptable.
•Disease Status:
•Disease must have failed standard therapy (therapies) or be a disease for which no standard therapy exists.
•Patient with stable disease on other therapies are not eligible.
•Performance Level:

Exclusion Criteria

•Patients who have received bevacizumab and/or Irinotecan previously are ineligible. Non brain tumor patients who have previously received Temozolomide are ineligible.
•Pregnancy or Breast-Feeding: Pregnant patients are ineligible for this study due to the known teratogenic effects of the cytotoxic agents. Pregnancy tests must be obtained in females of childbearing potential prior to enrollment.
•Lactating women must agree not to breast-feed.
•Males or females of reproductive age may not participate unless they have agreed to use an effective contraceptive method.
•Patients Who Have an Uncontrolled Infection will not be eligible for enrollment until all infections are under control.
•Clinically Significant Unrelated Systemic Illness: Patients with serious infections or significant pulmonary, hepatic, renal, or other end-organ dysfunction which in the judgment of the Principal or Co-Investigators would compromise the patient's ability to tolerate prescribed chemotherapy or are likely to interfere with the study procedures or results will not be eligible.