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
- 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.
- 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 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.
- 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.
- 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.