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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


Phase 1
12 Months
20 Years
Open (Enrolling)
Both
Refractory Solid Tumors in Children

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determination of maximum tolerated dose of Irinotecan in combination with vincristine, temozolomide and bevacizumab

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Rajkumar Venkatramani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Institutional Review Board

Study ID:

09-00214

NCT ID:

NCT00993044

Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Refractory Solid Tumors in Children
  • Neoplasms

Name

Location

Childrens Hospital Los AngelesLos Angeles, California  90027