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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00068991 | Other Identifier | JHMIRB |
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This research study is being done to see if lymphocytes can be collected from patients with high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are cells that normally circulate in the blood and are an essential part of the immune system). The investigators goal is to store these and give them back to the patient after radiation is completed. This is part of a larger effort that will attempt to preserve the immune system from the effects of radiation and chemotherapy.
The patients blood will be collected (apheresis) before starting the patients planned standard of care radiation therapy and chemotherapy:
Blood counts are obtained weekly as part of standard care for patients with this kind of brain tumor. For the first 14 weeks after the lymphocyte reinfusion we will be doing some extra tests on the routinely collected blood to see how the effective the reinfused lymphocytes are in raising the patients lymphocyte counts. These results will be available to the patients treating physician.
At no time will this study interfere with the patients planned standard of care radiation and chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphocyte harvesting & reinfusion | Experimental | Patients with a newly diagnosed high grade glioma (Grade III or IV), have a post-operative treatment plan that includes standard radiation and temozolomide, and have normal bone marrow function with Hematocrit ≥ 30%, platelet ≥ 100K, ANC ≥ 1000, and absolute lymphocyte count ≥ 1000 prior entry to this study are eligible for enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphocyte harvesting & reinfusion | Procedure | Lymphocytes will be collected and stored approximately one week prior to initiating concurrent radiation therapy (RT) and temozolomide (TMZ). Two lymphocyte collections are allowed. After the patient has completed 6 weeks of RT/TMZ, all of the collected lymphocytes will be re-infused. After lymphocyte re-infusion, Heme-8 and absolute lymphocyte count (ALC) will be checked per standard of care. The absolute increase in ALC as the primary endpoint will be assessed 4 weeks after lymphocyte re-infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| the feasibility of lymphocyte harvesting and reinfusion | this will be considered a feasible approach if 5 of the 10 patients to be accrued have an absolute lymphocyte count increase of 300 cells per mm3 at 4 weeks after reinfusion. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the number of lymphocytes that can be harvested in this pt population | the number of lymphocytes harvested per patient | 10 weeks |
| duration of lymphocyte rise following lymphocyte reinfusion | how long will lymphocyte counts remain elevated after reinfusion |
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Inclusion Criteria:
• Age≥18 year
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart A Grossman, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D008231 | Lymphopenia |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| 10 weeks |
| changes in lymphocyte subtypes following collection and reinfusion | changes in lymphocyte subtype between collection and reinfusion as a result of freezing for storage. | 10 weeks |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |