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Poor enrollment
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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade.
The primary aim of this study is:
To obtain pilot safety data on the use of simvastatin in young adults treated for HD.
The secondary aims of this study are:
To obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.
To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD.
To obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.
With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade.
The primary aim of this study is:
To obtain pilot safety data on the use of simvastatin in young adults treated for HD.
The secondary aims of this study are:
To obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.
To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD.
To obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.
We will do this by enrolling patients diagnosed with HD and evaluating the safety of simvastatin as evidenced by laboratory measures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Intervention Arm | Experimental | Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity | Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests. | Up to 26 weeks |
| Number of Participants Experiencing Grade 3 or Higher Liver Toxicity | Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests. | Up to 26 Weeks |
| Change in Carotid Intima-media Thickness Test (CIMT) | A change in CIMT measurements ( measured in millimeters (mm)) will be performed. | Up to 26 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Levine, MD | Columbia Univeristy Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Univeristy Medical Center | New York | New York | 10032 | United States |
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recruitment occurred in the late effects clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin | Escalating dose of simvastatin Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin | Escalating dose of simvastatin Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks. |
| 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 | Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity | Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests. | The study terminated in 2009 due to poor enrollment. The principal investigator (PI) and study team are no longer at the institution and the PI has confirmed that the data no longer exists. There are no data to report. | Posted | Up to 26 weeks |
|
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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 | Simvastatin | Escalating dose of simvastatin Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Creatine Kinase | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | S #1 at CHOP had increased CK:did not meet adverse event criteria. Later admitted to taking Androgel, not a study exclusion criteria but similar to a drug that was. PI at CHOP made decision to remove patient from study. Repeat CK wnl. |
Early termination due to poor accrual
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Levine, MD | Weill Cornell Medicine | 212-305-9770 | jel9022@med.cornell.edu |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Number of Participants Experiencing Grade 3 or Higher Liver Toxicity | Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests. | The study terminated in 2009 due to poor enrollment. The principal investigator (PI) and study team are no longer at the institution and the PI has confirmed that the data no longer exists. There are no data to report. | Posted | Up to 26 Weeks |
|
|
| Primary | Change in Carotid Intima-media Thickness Test (CIMT) | A change in CIMT measurements ( measured in millimeters (mm)) will be performed. | The study terminated in 2009 due to poor enrollment. The principal investigator (PI) and study team are no longer at the institution and the PI has confirmed that the data no longer exists. There are no data to report. | Posted | Up to 26 Weeks |
|
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| 0 |
| 3 |
| 2 |
| 3 |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | S#2 at CHOP developed rash, chose to stop taking medication. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |