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| Sponsor: | Giselle Sholler |
|---|---|
| Information provided by (Responsible Party): | Giselle Sholler, Van Andel Research Institute |
| ClinicalTrials.gov Identifier: | NCT01355679 |
Purpose
The purpose of this study is to test the feasibility (ability to be done) of an experimental test to help plan your cancer treatment. This study plan is not studying the effectiveness of the proposed combinations of therapy for your cancer that you may receive after the experimental testing.
This study will look at an experimental technology to determine a tumor's molecular makeup (gene expression profile). This technology (called "OncInsights") is being used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future. The experimental technology has not been approved by the U.S. Food and Drug Administration.
This study is for research purposes only. If you agree to participate in this study, a current specimen obtained from your tumor during a regular (standard of care) surgical biopsy or bone marrow procedure will be sent to the Van Andel Research Institute. Researchers will attempt to identify the molecular makeup within the specimen, as well as in your blood and urine samples. This additional testing is different than the routine tests currently performed at the hospital for the evaluation of cancer. If the investigators are unable to obtain enough neuroblastoma tumor cells for molecular makeup identification you will be unable to continue in the study.
| Condition | Intervention |
|---|---|
|
Neuroblastoma |
Device: Guided Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Feasibility Trial Using Molecular-Guided Therapy for the Treatment of Patients With Refractory or Recurrent Neuroblastoma |
| Estimated Enrollment: | 14 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Guided therapy
A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
|
Device: Guided Therapy
A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
|
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate liver function must be demonstrated, defined as:
Exclusion Criteria:
Contacts and Locations| Contact: Genevieve Bergendahl, RN | 616-234-5707 | genevieve.bergendahl@vai.org |
| United States, Connecticut | |
| Connecticut Children's Hospital | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Sherell Thornton-Thompson Sthornt@ccmckids.org | |
| Principal Investigator: Nehal Parikh, MD | |
| United States, Florida | |
| Arnold Palmer Hospital for Children- MD Anderson | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Michelle Pope, RN 321-841-8588 | |
| Principal Investigator: Don Eslin, MD | |
| United States, Maryland | |
| National Cancer Institute | Recruiting |
| Bethesda, Maryland, United States, 20877 | |
| Contact: Candace Menke 301-451-5007 menkecs@mail.nih.gov | |
| Principal Investigator: Melinda Merchant, MD | |
| United States, Michigan | |
| Helen DeVos Children's Hospital | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Emily Gleason 616-391-5075 Emily.gleason@helendevoschildrens.org | |
| Principal Investigator: Deanna Mitchell, MD | |
| Principal Investigator: Giselle Sholler, MD | |
| United States, Missouri | |
| Children's Mercy Hospitals and Clinics | Not yet recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Sara Soliman, RN 816-855-1977 sjsoliman@cmh.edu | |
| Principal Investigator: Kathleen Neville, MD | |
| Cardinal Glennon Children's Medical Center | Recruiting |
| St. Louis, Missouri, United States, 63104 | |
| Contact: Katherine Maxwell, RN 314-268-4000 | |
| Principal Investigator: William Ferguson, MD | |
| United States, North Carolina | |
| Levine Children's Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Mary Tipton, RN 704-355-1538 mary.tipton@carolinashealthcare.org | |
| Principal Investigator: Joel Kaplan, MD | |
| Study Chair: | Giselle Sholler, MD | The Van Andel Research Instititute |
| Study Chair: | Craig Webb, PhD | Van Andel Research Institute |
More Information
| Responsible Party: | Giselle Sholler, Study Chair, Van Andel Research Institute |
| ClinicalTrials.gov Identifier: | NCT01355679 History of Changes |
| Obsolete Identifiers: | NCT01375517 |
| Other Study ID Numbers: | NMTRC 001 |
| Study First Received: | May 13, 2011 |
| Last Updated: | April 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |