Clinical trial NCT00993044: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Refractory Solid Tumors in Children
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Bevacizumab (VIT-B) in patients with refractory solid tumors.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Rajkumar Venkatramani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venkatramani R, Malogolowkin M, Davidson TB, May W, Sposto R, Mascarenhas L. A phase I study of vincristine, irinotecan, temozolomide and bevacizumab (vitb) in pediatric patients with relapsed solid tumors. PLoS One. 2013 Jul 22;8(7):e68416. doi: 10.1371/journal.pone.0068416. Print 2013.