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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00091840 | Other Identifier | JHMIRB |
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Participant relapses led to abrupt stop of study.
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| Name | Class |
|---|---|
| The Matthew Larson Foundation for Pediatric Brain Tumors | OTHER |
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Participants enrolling on this study will receive standard of care chemotherapy for Wnt positive medulloblastoma without the radiation therapy or the weekly chemotherapy that is given during radiation therapy.
There will be 9 cycles of chemotherapy. There are two different kinds of cycles given. They are referred to as A and B.
Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. B cycles are given after the completion of two A cycles.
Below are the details of the drugs and schedules for A and B cycles.
Cycle A (This cycle lasts 42 days)
Cycle B (This cycle lasts 28 days)
You may also get a supportive care drug called a myeloid growth factor (filgrastim or pegfilgrastim). This drug will help your blood counts recover after the chemotherapy is given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Other | Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15. Cisplatin is given directly into a vein over 8 hours on Day 1. This cycle lasts 42 days. Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours. Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.This cycle lasts 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lomustine | Drug | Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | To determine the feasibility of treating newly diagnosed children with non-metastatic, standard risk, Wnt positive medulloblastoma with a chemotherapy-only approach. Primary outcome measure of this study will be progression-free survival; the number of participants who with progression free survival. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns of Failure | To evaluate the patterns of failure in those children that do not have progressive disease, progression free survival and overall survival. | 3 years |
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Inclusion Criteria:
No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF). Assessments must include MRI imaging of the brain and spine with and without contrast and a lumbar puncture for CSF cytology
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Cohen, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Childrens Hospital Hematology/Oncology | Phoenix | Arizona | 85016-7710 | United States | ||
| Children's Hospital Colorado Center for Cancer & Blood Disorders |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy | Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days. Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1. Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2016 | Oct 7, 2021 |
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| Vincristine | Drug | Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15. |
|
|
| Cisplatin | Drug | Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1. |
|
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| Cyclophosphamide | Drug | Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. |
|
|
| Mesna | Drug | Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours. |
|
|
| Vincristine | Drug | Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8. |
|
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| M D Anderson Cancer Center-Orlando Pediatric Hematology/Oncology | Orlando | Florida | 32806 | United States |
| All Children's Hospital Pediatric Hematology/Oncology | St. Petersburg | Florida | 33701 | United States |
| Children's Healthcare of Atlanta- Egleston Pediatric Neuro-Oncology | Atlanta | Georgia | 30322 | United States |
| Ann and Robert H Lurie Children's Hospital of Chicago Hematology/Oncology | Chicago | Illinois | 60611 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine Pediatric Hematology/Oncology | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Oregon Health and Science University Pediatric Hematology/Oncology | Portland | Oregon | 97239-3098 | United States |
| Seattle Children's Hospital Hematology/Oncology | Seattle | Washington | 98105 | United States |
| Childrens Hospital of Wisconsin (Medical College of Wisconsin) | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy | Chemo Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days. Chemo Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 and 2. MESNA, a drug to protect the bladder from effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide, repeated at 3 and 6 hours. Vincristine given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8. Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1. Vincristine: Chemo Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin: Chemo Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1. Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. Mesna: Chemo Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide, repeated at 3 & 6 hours. Vincristine: Chemo Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8. |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Progression Free Survival | To determine the feasibility of treating newly diagnosed children with non-metastatic, standard risk, Wnt positive medulloblastoma with a chemotherapy-only approach. Primary outcome measure of this study will be progression-free survival; the number of participants who with progression free survival. | This outcome was not assessed because some patients had a relapse and study was abruptly terminated. | Posted | 3 years |
|
| |||||||||||||||||||
| Secondary | Patterns of Failure | To evaluate the patterns of failure in those children that do not have progressive disease, progression free survival and overall survival. | This outcome was not assessed because some patients had a relapse and study was abruptly terminated. | Posted | 3 years |
|
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Adverse events were not collected for standard of care chemotherapy.
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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 | All Participants | Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day 1. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin given directly into a vein over 8 hours on Day 1. Cycle lasts 42 days. Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8.Cycle lasts 28 days Lomustine: Chemotherapy Cycle A Lomustine (CCNU) given by mouth on Day Vincristine: Chemotherapy Cycle A Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, & 15. Cisplatin: Chemotherapy Cycle A Cisplatin given directly into a vein over 8 hours on Day 1. Cyclophosphamide: Chemotherapy Cycle B Cyclophosphamide given into a vein over 1 hour on Days 1 & 2. Mesna: Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 & 6 hours. Vincristine: Chemotherapy Cycle B Vincristine given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 & 8. | 0 | 0 | 0 | 0 | 0 | 0 |
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Two of the participants relapsed not long into the study and the Data and Safety Management Committee (DSMC) recommended early closure of the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Cohen | Johns Hopkins University | (410) 614-5055 | kcohen@jhmi.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2016 | Oct 7, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 11, 2016 | Oct 7, 2021 | ICF_002.pdf |
| ID | Term |
|---|---|
| D008527 | Medulloblastoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D008130 | Lomustine |
| D014750 | Vincristine |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D015080 | Mesna |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|