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

CCI-09-00214

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.

2009-09-01

2013-02-01

2013-02-01

Completed

Early phase I

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.

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2023-10-06