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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA096888 | U.S. NIH Grant/Contract | View source | |
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| JHOC-J06143 | |||
| JHOC-NA_00007920 |
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Poor accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: Beginning 4-6 months after last chemotherapy, patients receive Hodgkin's antigens-GM-CSF-expressing cell vaccine on day 1. Treatment repeats every 3 weeks for up to 4 courses.
Immunologic responses are serially monitored along with disease status.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell vaccine after initial therapy for Hodgkin lymphoma | Experimental | Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hodgkin's antigens-GM-CSF-expressing cell vaccine | Biological |
| ||
| adjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Immunologic Response | 9 months | |
| Durability of Immunologic Response | 2 years | |
| Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses | 2 years | |
| Safety and Tolerability | After administration of last vaccine at 9 weeks |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Yvette L. Kasamon, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cell Vaccine After Initial Therapy for Hodgkin Lymphoma | Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cell Vaccine After Initial Therapy for Hodgkin Lymphoma | Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy |
| 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 | Immunologic Response | The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures. | Posted | 9 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 | Cell Vaccine After Initial Therapy for Hodgkin Lymphoma | Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvette Kasamon | Johns Hopkins Sidney Kimmel Cancer Center | 4109135018 | ykasamon@jhmi.edu |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| Procedure |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary | Durability of Immunologic Response | The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures. | Posted | 2 years |
|
|
| Primary | Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses | The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures. | Posted | 2 years |
|
|
| Primary | Safety and Tolerability | The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures. | Posted | After administration of last vaccine at 9 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |