Phase 1
Completed N=6
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
Refractory Solid Tumors in Children
Source: ClinicalTrials.gov NCT00993044 ↗
Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Jul 2014
Primary outcomePrimary: Dose Limiting Toxicity — 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Age: Patients must be > 12 months and 50% for patients >16 years of age and Lansky > 50 for children 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.
Data sourced from ClinicalTrials.gov (NCT00993044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.