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| ID | Type | Description | Link |
|---|---|---|---|
| PEDS008 | Other Identifier | University of Florida |
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This is a rare disease, and enrollment was poor.
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This is a pilot study to evaluate the response rates for patients undergoing high dose conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in children, adolescents, and young adults.
The use of high dose chemotherapy followed by autologous peripheral blood stem cell (PBSC) transplantation in recurrent nasopharyngeal carcinoma has shown promise when compared with standard chemotherapy. This study has been designed to evaluate response rates and toxicities associated with undergoing high dose conditioning with Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation support in the treatment of recurrent nasopharyngeal carcinoma in children, adolescents, and young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Conditioning | Experimental | Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide phosphate | Drug | Etoposide is one of three drugs used in the high-dose conditioning phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Tumor Response | To evaluate the response rates for patients undergoing high dose conditioning using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent NPC in children, adolescents, and young adults. | 12 months after completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Fort, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health Shands Hospital | Gainesville | Florida | 32610 | United States |
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The protocol was terminated due to poor enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Conditioning | Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase. Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Conditioning | Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase. Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm. |
| 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 | Evaluate the Tumor Response | To evaluate the response rates for patients undergoing high dose conditioning using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent NPC in children, adolescents, and young adults. | Due to only one subject being enrolled data analysis was completed | Posted | 12 months after completion of treatment |
|
6 months
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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 | High Dose Conditioning | Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation Etoposide phosphate: Etoposide is one of three drugs used in the high-dose conditioning phase Carboplatin: Carboplatin is one of the drugs used in the high-dose conditioning phase. Ifosfamide: Ifosfamide is one of the drugs used in the high-dose conditioning phase Autologous Stem Cell Transplantation: Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade III Hypophosphatemia | Blood and lymphatic system disorders | Systematic Assessment |
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Early termination leading to no subject data analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Fort, MD | University of Florida | 352-273-9120 | john.fort@ufl.edu |
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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 | Mar 23, 2017 | May 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C061400 | etoposide phosphate |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| D007069 | Ifosfamide |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Carboplatin | Drug | Carboplatin is one of the drugs used in the high-dose conditioning phase. |
|
|
| Ifosfamide | Drug | Ifosfamide is one of the drugs used in the high-dose conditioning phase |
|
|
| Autologous Stem Cell Transplantation | Procedure | Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm. |
|
| 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 |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| 0 |
| 1 |
| Grade III Mucositis | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Immune system disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |