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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00831844 |
Purpose
RATIONALE: Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Adrenocortical Carcinoma Kidney Cancer Liver Cancer Neuroblastoma Retinoblastoma Sarcoma |
Biological: cixutumumab Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND #100947, NSC #742460) in Children With Relapsed/Refractory Solid Tumors |
| Estimated Enrollment: | 140 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to disease type.
Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative laboratory studies. Samples are analyzed for IGF-I, IGF-II, IGF-BP3, growth hormone, insulin, and C-peptide levels and for immunogenicity.
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor, including the following:
Radiographically measurable disease*, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by MRI or CT scan or ≥ 10 mm by spiral CT scan
The following are not considered measurable disease:
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine normal based on age/gender as follows:
PRIOR CONCURRENT THERAPY:
At least 2 months since prior stem cell transplantation
Concurrent corticosteroids allowed provided dose is stable or decreasing over the past 7 days
Contacts and Locations
Show 109 Study Locations| Study Chair: | Brenda Weigel, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00831844 History of Changes |
| Other Study ID Numbers: | CDR0000633186, COG-ADVL0821 |
| Study First Received: | January 28, 2009 |
| Last Updated: | April 2, 2011 |
| Health Authority: | Unspecified |
|
recurrent osteosarcoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor adult rhabdomyosarcoma previously treated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma recurrent adult soft tissue sarcoma recurrent childhood soft tissue sarcoma adult synovial sarcoma |
childhood synovial sarcoma recurrent adrenocortical carcinoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors childhood hepatoblastoma recurrent childhood liver cancer recurrent retinoblastoma |
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Liver Neoplasms Neuroblastoma Retinoblastoma Adrenocortical Carcinoma Sarcoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Digestive System Neoplasms Digestive System Diseases Liver Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Retinal Neoplasms Eye Neoplasms Eye Diseases Retinal Diseases |