Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085111 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bevacizumab in treating young patients with refractory solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of Bevacizumab In Refractory Solid Tumors |
Study Start Date: | December 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-8 months.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Patients without bone marrow involvement:
Patients with bone marrow metastases:
Hepatic
Renal
Creatinine based on age as follows:
Cardiovascular
No uncontrolled hypertension
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 2 months since prior stem cell transplantation
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 1 week since prior full-dose anticoagulation therapy, including systemic thrombolytic agents, heparin, low-molecular weight heparin, and warfarin
Study Chair: | Julia L. Glade-Bender, MD | Herbert Irving Comprehensive Cancer Center |
Investigator: | Darrell J. Yamashiro, MD, PhD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000367299, COG-ADVL0314, NCI-04-C-0148 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00085111 |
Health Authority: | United States: Federal Government |
unspecified childhood solid tumor, protocol specific |
Bevacizumab |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |