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Investigator is leaving Dartmouth
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| Name | Class |
|---|---|
| University of Vermont | OTHER |
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This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.
The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be done twice and separated by one week. The first vaccination will be performed approximately 2 weeks after surgery.
Approximately one week after the second vaccination one or two vaccine-draining lymph node(s) will be removed. The lymph node(s) will be identified using SN technology. One or two lymph node(s) will be removed.
Lymph nodes will be processed for recovery of B cells and formation of hybridomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor Vaccine | Experimental | 1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Vaccine | Biological | Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG. |
| Measure | Description | Time Frame |
|---|---|---|
| number of hybridoma clones that produce anti-glioma antibodies | The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Production of Antibodies | Secondary outcomes will include: Determining how many hybridoma clones produce glioblastoma-specific antibodies. The initial secondary endpoint will include the counting of the number of hybridoma clones sourced from the dermal vaccine draining lymph nodes that generate specific glioma antibodies. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Binding Characteristics | Exploratory objectives will include:
| 6 months |
Inclusion Criteria:
Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL
Exclusion Criteria:
A patient may not be enrolled in the trial if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Camilo Fadul, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D019496 | Cancer Vaccines |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Toxicity of Vaccine |
• Determining toxicity of vaccine |
| 6 months |
| Clone Production Rate | Determining whether B cells sourced from the vaccine nodes produce more anti-tumor antibody hybridomas than the non-vaccine node. The rate of producing these clones will be compared according to the source of the B cells. Thus, B cells recovered from vaccine related nodes will be compared to B cells recovered from the non-vaccine node. | 6 months |
| Lymph Node Biopsy | Determine the safety and toxicity issues related to the Lymph Node Biopsy | 6 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |