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| ID | Type | Description | Link |
|---|---|---|---|
| DCREN-005-01 |
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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This study will look how using taken from your tumors and mixed with special immune stimulating cells from another person's blood in given back to you in a series "fusion cell" injections, will effect your body. The primary goal of the study is to see if giving the experimental fusion cell injections is safe. We will also be looking to see what effect the experimental treatment as on your immune system and whether it has an effect on your cancer.
Patients undergo tumor aquisition and short-term tumor cell cultures are established. Leukopheresis is performed monocyte-derived DC are generated ex-vivo by standard culture techniques, utilizing GM-CSF and Il-4. PEG fusions are generated, and following irradiation, the vaccine is frozen. The thawed vaccine is administered SC into a single site every three weeks. Each study is examining a dose-escalating strategy based apon the number PEG-fused generated from the PEG process that expressed both tumor cell and DC markers as determined by immune staining.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrofusion DC vaccine | Biological | To assess the safety and efficacy of vaccinations |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of 3 serial vaccinations with allogeneic DCs: autologous tumor-derived cells subjected to electrofusion in patients with AJCC stage IV RCC | screening/baseline, treatment period, follow-up and long-term follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if 3 serial vaccinations of allogeneic DCs: autologous tumor-derived cells subjected to electrofusion will induce a clinical response as assessed by tumor response and will induce an immune response. | screening/baseline, treatment period, follow-up and long-term follow-up |
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Inclusion Criteria:
The patient must be _> 18 years of age
The patient must be diagnosed with AJCC stage IV (primary or relasped) RCC
The patient must have a baseline Eastern Cooperative Oncology Group (ECOG) Clinical performance of 0-1
The patient must have accessible tumor (minimum of 2.5cm in diameter in aggregate and accessible) for vaccine production
The patient must have measurable tumor lesions (using Response Evaluation Criteria in Solid Tumors (RECIST) following resection of tumor lesions(s) used for vaccine production. If the patient has received previous radiation or intra-tumoral investigational treatments, the measurable disease must be outside the previous radiation port or treatment area unless there is documented tumor progression following the completion of therapy.
The patient must have adequate hematologic, hepatic, and renal function parameters within 21 days prior to the first vaccination (day 0 of treatment):
The patient must be serologically negative for human immunodeficiency virus (HIV)-1, HIV-2, and human T lymphotropic virus (HTLV)-1
Female patients of childbearing potential must have negative pregnancy tests, refrain from nursing and must agree ton use appropriate contraception for the duration of the trial
The patient must have signed and dated written informed consent prior to any study procedures. The consent process must be documented in the patient's medical record
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Avigan, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIDMC | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17893567 | Result | Avigan DE, Vasir B, George DJ, Oh WK, Atkins MB, McDermott DF, Kantoff PW, Figlin RA, Vasconcelles MJ, Xu Y, Kufe D, Bukowski RM. Phase I/II study of vaccination with electrofused allogeneic dendritic cells/autologous tumor-derived cells in patients with stage IV renal cell carcinoma. J Immunother. 2007 Oct;30(7):749-61. doi: 10.1097/CJI.0b013e3180de4ce8. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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