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Phase 1 Completed N=6 Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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