Refractory Solid Tumors in Children Clinical Trial
— VIT-BOfficial 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
| Verified date | September 2023 |
| Source | Children's Hospital Los Angeles |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Months to 20 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Childrens Hospital los Angeles | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Los Angeles |
United States,
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/ — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dose Limiting Toxicity | Number of participants with dose limiting toxicity events | 2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01282697 -
Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
|
Phase 1 |