Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Physician decided not to go through with study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal RT, Temozolomide, Stem Cell Collection/Reinfusion | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy | Radiation |
| ||
| Temozolomide |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event | The study will provide preliminary evidence of efficacy if ā„5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ā„300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts. | Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lymphocyte stem cells that can be harvested from this patient population | Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months) | |
| Proportion of patients who have an increase in lymphocyte of ā„300 cells/mm^3 after autologous stem cell reinfusion. |
Not provided
Inclusion Criteria:
Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III or IV).
At least 18 years of age.
Karnofsky performance status ā„ 60%
Normal bone marrow and organ function as defined below:
Post-operative treatment plan must include standard radiation and temozolomide.
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jian Li Campian, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
Not provided
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Stem cell collection | Procedure |
|
| Stem cell infusion | Procedure |
|
| 4 weeks after stem cell reinfusion |
| Duration of lymphocyte rise following stem cell reinfusion | Up to 6 months after stem cell reinfusion (approximately 9 months) |
| Changes in lymphocyte subtypes following collection and reinfusion | Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months. | Up to 6 months after stem cell reinfusion (approximately 9 months) |
| Changes in series of cytokine levels following collection and reinfusion | Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months. | Up to 6 months after stem cell reinfusion (approximately 9 months) |
| Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events | the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting. | Up to 6 months after stem cell reinfusion (approximately 9 months) |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D005910 | Glioma |
| D009837 | Oligodendroglioma |
| D020339 | Optic Nerve Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided