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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02927 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 3405 | |||
| CASE 3405-CC304 | Other Identifier | Case Comprehensive Cancer Center | |
| 7080 | Other Identifier | CTEP | |
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| R21CA115057 | U.S. NIH Grant/Contract | View source | |
| U01CA062502 | U.S. NIH Grant/Contract | View source |
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This phase I/II trial studies the side effects and best dose of carmustine when given together with O6-benzylguanine and to see how well they work in treating patients with stage IA-IIA cutaneous T-cell lymphoma. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help carmustine work better by making cancer cells more sensitive to the drug. Giving O6-benzylguanine with carmustine may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the cutaneous T-cell Lymphoma (CTCL) response rate and safety of O6BG (O6-benzylguanine) /BCNU (carmustine) when given biweekly as two consecutive daily doses.
SECONDARY OBJECTIVES:
I. To determine the laboratory correlates of clinical response and drug efficacy based upon O6-alkylguanine deoxyribonucleic acid (DNA) alkyltransferase (AGT) activity in CTCL lesions will be examined to determine the effects of consecutive day O6BG administration on the extent and duration of AGT depletion.
II. To determine the laboratory correlates of clinical response and drug efficacy based upon degree of induction of apoptosis and cell cycle arrest will be examined in the malignant T-cell population of lymphomatous tissue and in the constitutive cells of the skin to determine drug efficacy and toxicity through immunohistochemical techniques.
III. To determine the laboratory correlates of clinical response and drug efficacy based upon O-6-methylguanine-DNA methyltransferase (MGMT) gene mutations and changes in AGT expression will be examined as potential mechanisms for O6BG resistance in non-responding patients.
OUTLINE: This is a phase I, dose-escalation study of carmustine followed by a phase II study.
Patients receive O6-benzylguanine intravenously (IV) over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (O6-benzylguanine, carmustine) | Experimental | Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carmustine | Drug | Applied topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Based on changes in modified SWAT assessment, patient responses will be classified as complete clinical response (CCR), partial response (PR), stable disease (SD), or progressive disease (PD). SWAT provides an accurate and reproducible assessment of cutaneous disease involvement based on body surface area of involvement and lesional thickness. CCR: No evidence of disease, 100% improvement for a duration of at least 4 weeks. PR: Greater than or equal to 50% decrease in SWAT score compared to baseline and improvement is maintained for at least 4 weeks. SD: Less than 50% decrease in SWAT score compared to baseline. PD: Increase of greater or equal to 25% of the SWAT score compared to baseline while the patient is actively taking the study drug | Up to 2 weeks after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity | Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. | Baseline |
| Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Cooper | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States | ||
| Case Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28199478 | Derived | Tacastacas JD, Chan DV, Carlson S, Gerson SL, Dowlati A, Fu P, Lu K, Groft S, Rosenjack J, Honda K, McCormick TS, Cooper KD. Evaluation of O6-Benzylguanine-Potentiated Topical Carmustine for Mycosis Fungoides: A Phase 1-2 Clinical Trial. JAMA Dermatol. 2017 May 1;153(5):413-420. doi: 10.1001/jamadermatol.2016.5793. |
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Patients were recruited from February 2010 to November 2013 from University Hospital Case Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (O6-benzylguanine, Carmustine) | Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only). laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| O6-Benzylguanine | Drug | Given IV |
|
|
Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. |
| 24 hours after the first infusion |
| Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity | Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. | 48 hours after the first infusion |
| Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity | Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. | 1 week after the first infusion |
| Changes in the Apoptosis | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results. | at 24 hours after the first infusion |
| Changes in the Apoptosis | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results. | at 48 hours after the first infusion |
| Changes in the Cell Cycle/Proliferation | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results. | at 24 hours after the first infusion |
| Changes in the Cell Cycle/Proliferation | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results. | at 48 hours after the first infusion |
| Changes in DNA Damage- Cytotoxicity | Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells | 24 hours after the first infusion |
| Changes in DNA Damage- Cytotoxicity | Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells | 48 hours after the first infusion |
| Changes in AGT Inactivation in Non-responding Patients | Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment. | After first course at 2 weeks |
| Changes in AGT Inactivation in Non-responding Patients | Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment. | After seventh course at 14 weeks |
| Cleveland |
| Ohio |
| 44106-5065 |
| United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention to treat
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (O6-benzylguanine, Carmustine) | Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only). laboratory biomarker analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | 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 |
|
| 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 | Overall Response Rate | Based on changes in modified SWAT assessment, patient responses will be classified as complete clinical response (CCR), partial response (PR), stable disease (SD), or progressive disease (PD). SWAT provides an accurate and reproducible assessment of cutaneous disease involvement based on body surface area of involvement and lesional thickness. CCR: No evidence of disease, 100% improvement for a duration of at least 4 weeks. PR: Greater than or equal to 50% decrease in SWAT score compared to baseline and improvement is maintained for at least 4 weeks. SD: Less than 50% decrease in SWAT score compared to baseline. PD: Increase of greater or equal to 25% of the SWAT score compared to baseline while the patient is actively taking the study drug | Intention to treat | Posted | Number | participants | Up to 2 weeks after completion of study treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity | Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | Baseline |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity | Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | 24 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity | Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | 48 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity | Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | 1 week after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Apoptosis | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | at 24 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Apoptosis | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | at 48 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Cell Cycle/Proliferation | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | at 24 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in the Cell Cycle/Proliferation | Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | at 48 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in DNA Damage- Cytotoxicity | Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | 24 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in DNA Damage- Cytotoxicity | Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | 48 hours after the first infusion |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in AGT Inactivation in Non-responding Patients | Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | After first course at 2 weeks |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in AGT Inactivation in Non-responding Patients | Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment. | Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes. | Posted | After seventh course at 14 weeks |
|
|
Adverse events were collected from during treatment over a 6 month time period.
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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 | Treatment (O6-benzylguanine, Carmustine) | Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only). laboratory biomarker analysis: Correlative studies | 0 | 17 | 16 | 17 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACNEIFORM RASH | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| ALKALINE PHOSPHATASE ELEVATED | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| BLOATING | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| CREATININE ELEVATION | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| CUTANEOUS HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| GLUCOSE LOW | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| INJECTION SITE REACTION or PAIN | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| JOINT PAINS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| MONOCYTE ELEVATION | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| RASH/ DESQUAMATION | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| SKIN ULCERATION | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| TELANGIECTASIA | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| TOTAL BILIRUBIN ELEVATED | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| TRANSAMINASE ELEVATION | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| URIC ACID ELEVATION | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| URINE SPECIFIC GRAVITY ELEVATED | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Cooper | Case Comprehensive Cancer Center | 216-844-3111 | kevin.cooper@uhhospitals.org |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002330 | Carmustine |
| C574855 | carmustine, poliferprosan 20 drug combination |
| C064976 | O(6)-benzylguanine |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 50-59 years |
|
| 60-69 years |
|
| 70-79 years |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|