A Phase I Study of Pazopanib as a Single Agent for Children With Refractory Solid Tumors
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Purpose
Background:
- Pazopanib, a drug that inhibits the growth of new blood vessels in tumors, was recently approved by the Food and Drug Administration to treat advanced kidney cancer in adults. Pazopanib has been used in only a small number of adults, and more research is needed on whether it is safe and effective to use in children. Researchers are interested in determining safe and effective treatment doses of pazopanib in children, and in other studies will examine which form of pazopanib treatment (tablet or liquid) is most effective and well tolerated.
Objectives:
- To determine a safe and effective dose of pazopanib to treat solid tumors in children.
- To study the effects of pazopanib on blood cells, blood flow, and human development.
Eligibility:
- Children, adolescents, and young adults between 1 and 21 years of age who have been diagnosed with solid tumors that have not responded to treatment.
Design:
- Eligible participants will be screened with a physical examination, blood and tumor samples, and imaging studies.
- Participants will receive pazopanib tablets for 28-day cycles of treatment. Pazopanib should be taken on an empty stomach, at least 1hour before or 2 hours after a meal. Participants may receive pazopanib for up to 24 cycles unless the tumor does not respond or participants develop serious side effects.
- Blood samples will be taken on days 1, 15, 22, and 27 of the first cycle of pazopanib, with additional samples taken every 8 weeks during subsequent cycles.
- An optional part of the study will collect additional blood samples at regular intervals for 24 hours after the first dose of pazopanib and at regular intervals after another dose during the second or third week of the first treatment cycle.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma Neuroblastoma Wilms Tumor Osteosarcoma Brain Tumor |
Drug: Pazopanib (GW786034) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Pazopanib as a Single Agent for Children With Relapsed or Refractory Solid Tumors, Including CNS Tumors |
- To estimate MTD and Phase II dose of oral pazopanib.
- To define the toxicities of oral pazopanib tablet or suspension.
- To characterize PKs.
- To define antitumor and biologic activity and explore changes in tumor vascular permeability. To assess VEGF haplotype/phenotype relationships and explore concentration-effect with biomarkers and clinical outcomes.
| Enrollment: | 0 |
| Study Start Date: | May 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
-
Drug: Pazopanib (GW786034)
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Eligibility:
Part 1 (Phase I Dose Escalation) and 2a (Suspension Formulation Component):
--Patients greater than 12 months and less than or equal to 21 years of age with measureable or evaluable relapsed or refractory solid tumors including CNS tumors with histologic verification except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevation of tumor markers.
Part 2b (Expanded Imaging Cohort):
--Patients greater than 2 years and less than or equal to 25 years of age with histologically verified relapsed or refractory soft tissue sarcoma, desmoplastic small round cell tumor or extraosseus Ewing sarcoma with measurable disease (greater than or equal to 2 cm) in the head, neck, extremity or fixed within the thorax, abdomen or pelvis.
- Performance score: Karnofsky greater than or equal to 50% for patients 16 years of age; Lansky greater than or equal to 50 for patients less than or equal to 16 years of age.
- Must have fully recovered from acute toxic effects from all prior therapy which have been completed within the specified prior time frame. Have adequate organ function as determined by laboratory evaluation.
Contacts and Locations More Information
Publications:
| Responsible Party: | CTEP/National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT01130623 History of Changes |
| Other Study ID Numbers: | 100120, 10-C-0120 |
| Study First Received: | May 25, 2010 |
| Last Updated: | December 30, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
VEGF Inhibitor Maximum Tolerated Dose Dose Escalation Pharmacokinetics Antitumor Activity Pediatric Cancer |
Solid Tumor Sarcoma Neuroblastoma Wilms Tumor Osteosarcoma Brain Tumor |
Additional relevant MeSH terms:
|
Brain Neoplasms Wilms Tumor Neuroblastoma Osteosarcoma Sarcoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type Kidney Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplastic Syndromes, Hereditary Kidney Diseases Urologic Diseases Genetic Diseases, Inborn Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue |
ClinicalTrials.gov processed this record on May 23, 2013