Status:
COMPLETED
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
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Refractory Solid Tumors in Children
Eligibility:
All Genders
12-20 years
Phase:
PHASE1
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 Bevaciz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00993044
Start Date
September 1 2009
End Date
February 1 2013
Last Update
October 6 2023
Active Locations (1)
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1
Childrens Hospital los Angeles
Los Angeles, California, United States, 90027