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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided therapy | Experimental | A total of 14 eligible 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Therapy | Device | A total of 14 eligible 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Are Able to Meet Feasibility Parameters. | Feasibility parameter defined as: Enrollment onto study, quality mRNA obtained, gene chip completed, tumor board held, medical monitor review and approval, start of treatment by 21 days post biopsy/surgical resection date, and then completion of 1 cycle of therapy." | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | To determine the safety of allowing a molecular tumor board to determine individualized treatment plans | 1 year |
| Overall Response Rate (ORR) of Participants Using RECIST Criteria |
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Inclusion Criteria:
Patients must have histologically proven neuroblastoma and confirmation of refractory or recurrent disease with histologic confirmation at diagnosis or at the time of recurrence/progression
Patients must be age > 12 months and ≤ 21 at initial diagnosis.
Life expectancy must be more than 3 months
If measurable disease, this must be demonstrated by residual abnormal tissue at a primary or metastatic site measuring more than 1 cm in any dimension by standardized imaging (CT or MRI); tumor must be accessible for biopsy. Patients with bone marrow only disease expected to be > 75% are eligible to enroll.
Current disease state must be one for which there is currently no known curative therapy
Lansky or KarnofskyScore must be more than 50
Patients without bone marrow metastases must have an ANC > 750/μl and platelet count > 50,000/μl
Adequate liver function must be demonstrated, defined as:
No other significant organ toxicity defined as > Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events NCI-CTCAE V4.0
A negative serum pregnancy test is required for female participants of child bearing potential (≥ 13 years of age or after onset of menses)
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines. Voluntary consent for optional biology studies will be included.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giselle Sholler, MD | Beat Childhood Cancer at Atrium Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Hospital | Hartford | Connecticut | 06106 | United States | ||
| Arnold Palmer Hospital for Children- MD Anderson |
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| Label | URL |
|---|---|
| Beat Childhood Cancer | View source |
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This was an open label, multi-center prospective feasibility study in patients with refractory or recurrent neuroblastoma that enrolled at NMTRC centers across the country between 8/11/2011 and 11/26/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Multiply relapsed or refractory neuroblastoma.
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| ID | Title | Description |
|---|---|---|
| BG000 | Guided Therapy | All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants That Are Able to Meet Feasibility Parameters. | Feasibility parameter defined as: Enrollment onto study, quality mRNA obtained, gene chip completed, tumor board held, medical monitor review and approval, start of treatment by 21 days post biopsy/surgical resection date, and then completion of 1 cycle of therapy." | All subjects had soft tissue disease in which biopsy was possible. Two subjects were deemed ineligible due to benign tumor type after biopsy. | Posted | Number | percentage of participants | 1 year |
|
Time on therapy plus 30 days after last dose and until all related events resolved, an average of 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guided Therapy | A total of 14 eligible 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giselle Sholler, MD | NMTRC at Spectrum Health | 616-267-0334 | giselle.sholler@helendevoschildrens.org |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| 1 year |
| Activity of Treatments Chosen Based on Progression Free Survival (PFS) | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 1 year |
| Orlando |
| Florida |
| 32806 |
| United States |
| National Cancer Institute | Bethesda | Maryland | 20877 | United States |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | United States |
| Levine Children's Hospital | Charlotte | North Carolina | 28204 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety | To determine the safety of allowing a molecular tumor board to determine individualized treatment plans | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Overall Response Rate (ORR) of Participants Using RECIST Criteria | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Number | percentage of participants with PR or CR | 1 year |
|
|
|
| Secondary | Activity of Treatments Chosen Based on Progression Free Survival (PFS) | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | Posted | Mean | 95% Confidence Interval | Days | 1 year |
|
|
|
| 0 |
| 14 |
| 12 |
| 14 |
| ALT elevation | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| AST Elevation | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Elevated Bilirubin | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fever | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypoalbunemia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypocalcemia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypophosphatemia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Lymphocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Myalgia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Weight Loss | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |