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The study never opened and not sure if it ever will.
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The purpose of the study is to gather data on feasibility and on immune and clinical efficacy of intratumoral dendritic cell (DC) vaccination in combination with local radiotherapy in patients with recurrent lymphoma
Lymphoma is extremely sensitive to radiation and is a commonly used therapy. The major issue in application of local radiotherapy is the relative short duration of response and as a consequence is used mainly for palliation. Therefore novel therapies are needed to improve the outcome of patients with lymphomas. The potential specificity of the immune system to recognize and eliminate tumor cells is especially relevant in lymphoma. Immune responses are induced, coordinated and regulated by dendritic cells (DCs), the most potent antigen-presenting cells. Based on the central role of DCs in initiating immune responses, four vaccinations will be administered at intervals beginning two days after low dose radiation is given to the tumor site.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS | Biological | Day 1 and Day 2: 2 Gy Radiation on Day 1 and Day 2 to tumor site. Day 4, 8, 11, 18: 0.5mL injection of Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and feasibility of intratumoral dendritic cell vaccination | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical activity-response in local and distant lesions | 2 years | |
| Immunological response with conventional CTL assay, proliferation assay and microarray-based immune gene profiling using peripheral blood and/or biopsied tumor | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karolina Palucka, MD, PhD | Study Director |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D008070 | Lipopolysaccharides |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D008055 | Lipids |
| D000942 | Antigens, Bacterial |
| D000941 | Antigens |
| D004731 | Endotoxins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |