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

Phase 1

Completed

• Conditions: Refractory Solid Tumors in Children
• Interventions: Drug: Irinotecan; Drug: Vincristine; Drug: Temozolomide; Drug: Bevacizumab

• Registration Number: NCT00993044
• Lead Sponsor: Children's Hospital Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-01-03
• Results First Submitted QC: 2014-07-21
• Results First Posted: 2014-07-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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:

• Karnofsky > 50% for patients >16 years of age and Lansky > 50 for children < 16 years of age (Appendix I).
• Life Expectancy: Must be > 8 weeks.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Vincristine	-
Single Arm	Irinotecan	-
Single Arm	Temozolomide	-
Single Arm	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	2 years	Number of participants with dose limiting toxicity events

Trial Locations

Locations (1)

Childrens Hospital los Angeles; 🇺🇸 Los Angeles, California, United States