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 (VIT-B)

Children's Hospital Los Angeles

Status and phase

Completed

Phase 1

Conditions

Refractory Solid Tumors in Children

Treatments

Drug: Irinotecan

Drug: Temozolomide

Drug: Bevacizumab

Drug: Vincristine

Study type

Interventional

Funder types

Other

Identifiers

NCT00993044

CCI-09-00214

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

12 months to 20 years old

Volunteers

No Healthy Volunteers

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.