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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-260 | Other Identifier | Spectrum Health |
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Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in severe pain, physical disability, organ dysfunction and/or become life-threatening. Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform neurofibromas, and surgery does not provide lasting help. This study will evaluate the effectiveness of two treatment combinations in patients with "high-risk" plexiform neurofibromas.
The study's design involves treating eligible patients with a combination of celecoxib and pegylated interferon alpha-2b. If the patients have at least a partial response after six months, they may continue on the same treatment for up to two years. If the patient experiences less than a partial response, or has progressive disease after six months of therapy, then vincristine and temozolomide will be added to the celecoxib and interferon alpha-2b backbone. Response to treatment will be assessed after a minimum of six months, presuming the patient has not experienced progressive disease. Total duration of therapy on study is two years for any individual treatment plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label Intervention | Experimental | This is a phase II single arm study with sequential treatments available by response where all participants begin therapy with a combination of celecoxib and interferon alpha-2b (CI, treatment-1). Response to CI therapy will be assessed at six months by clinical and radiographic evaluations. Those patients who have achieved a partial response (improvement in pain, improvement in functioning, or ≥50% reduction in tumor size) or complete response (resolution of pain, and normalization of functioning with a ≥ 90% reduction in tumor size) will continue with the same CI therapy for up-to two years on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-Interferon alpha-2b | Drug | age and weight dependant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Symptoms and Pain | Subjects will be evaluated for pain and Quality of Life scores | Monthly physical exam first three months and then every three months after, for up to 36 months |
| At Least 50% Shrinkage in Tumor Measurements by Physical Examination | Monthly physical exam first three months and then every three months after, for up to 36 months | |
| Response by MRI Measurements | partial response by RICST criteria is defined as >50% tumor shrinkage | evaluated 6, 12 and 24 months compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| No Reported Psychological Toxicity Based Upon Psychological Evaluations | Psychological toxicity defined as suicidal ideation | Psychological evaluation at 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert S Cornelius, MD | Helen DeVos Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
Period 1: Baseline to 6 months", "Period 2: After 6 month evaluation for addition of vincristine and temozolomide", if accurate and appropriate
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label Intervention | This is a phase II single arm study with sequential treatments available by response where all participants begin therapy with a combination of celecoxib and interferon alpha-2b (CI, treatment-1). Response to CI therapy will be assessed at six months by clinical and radiographic evaluations. Those patients who have achieved a partial response (improvement in pain, improvement in functioning, or ≥50% reduction in tumor size) or complete response (resolution of pain, and normalization of functioning with a ≥ 90% reduction in tumor size) will continue with the same CI therapy for up-to two years on study. Peg-Interferon alpha-2b: age and weight dependant Celecoxib (Celebrex): age and weight dependant Temozolomide (temodar): age and weight dependant Vincristine Sulfate (Oncovin): age and weight dependant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-Label Intervention | This is a phase II single arm study with sequential treatments available by response where all participants begin therapy with a combination of celecoxib and interferon alpha-2b (CI, treatment-1). Response to CI therapy will be assessed at six months by clinical and radiographic evaluations. Those patients who have achieved a partial response (improvement in pain, improvement in functioning, or ≥50% reduction in tumor size) or complete response (resolution of pain, and normalization of functioning with a ≥ 90% reduction in tumor size) will continue with the same CI therapy for up-to two years on study. Peg-Interferon alpha-2b: age and weight dependant Celecoxib (Celebrex): age and weight dependant Temozolomide (temodar): age and weight dependant Vincristine Sulfate (Oncovin): age and weight dependant |
| 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 | Improvement of Symptoms and Pain | Subjects will be evaluated for pain and Quality of Life scores | Posted | Count of Participants | Participants | Monthly physical exam first three months and then every three months after, for up to 36 months |
|
collected over 5 years
adverse events collected during provider appointments
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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 | Open-Label Intervention | This is a phase II single arm study with sequential treatments available by response where all participants begin therapy with a combination of celecoxib and interferon alpha-2b (CI, treatment-1). Response to CI therapy will be assessed at six months by clinical and radiographic evaluations. Those patients who have achieved a partial response (improvement in pain, improvement in functioning, or ≥50% reduction in tumor size) or complete response (resolution of pain, and normalization of functioning with a ≥ 90% reduction in tumor size) will continue with the same CI therapy for up-to two years on study. Peg-Interferon alpha-2b: age and weight dependant Celecoxib (Celebrex): age and weight dependant Temozolomide (temodar): age and weight dependant Vincristine Sulfate (Oncovin): age and weight dependant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment | hospitalized for suicidal ideation, expected side effect of interferon. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | difficulty maintaining school attendance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Albert Cornelius | Corewell Health | 616-391-2086 | albert.cornelius@helendevoschildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2010 | May 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009456 | Neurofibromatosis 1 |
| D009455 | Neurofibroma |
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D000068579 | Celecoxib |
| D000077204 | Temozolomide |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Celecoxib (Celebrex) |
| Drug |
age and weight dependant |
|
| Temozolomide (temodar) | Drug | age and weight dependant |
|
| Vincristine Sulfate (Oncovin) | Drug | age and weight dependant |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | At Least 50% Shrinkage in Tumor Measurements by Physical Examination | Posted | Count of Participants | Participants | Monthly physical exam first three months and then every three months after, for up to 36 months |
|
|
|
| Primary | Response by MRI Measurements | partial response by RICST criteria is defined as >50% tumor shrinkage | Posted | Number | participants | evaluated 6, 12 and 24 months compared to baseline |
|
|
|
| Secondary | No Reported Psychological Toxicity Based Upon Psychological Evaluations | Psychological toxicity defined as suicidal ideation | Posted | Count of Participants | Participants | Psychological evaluation at 24 months |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 1 |
| 9 |
|
|
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| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| Title | Measurements |
|---|---|
|
| Partial Response at 12 months |
|
| Complete Response at 12 months |
|
| Less than Partial Response at 12 months |
|
| Partial Response at 24 months |
|
| Complete Response at 24 months |
|
| Less than Partial Response at 24 months |
|
| no longer participating at 24 months |
|