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This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.
This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLH + anti-OX40 | Experimental | Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine |
|
| Tetanus vaccine + anti-OX40 | Experimental | Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 anti-OX40 | Drug | 0.1 mg/kg anti-OX40 on days 1, 3, and 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | A dose limiting toxicity is defined as any grade >=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | Blood tests and leukapheresis product will be collected to determine the response to three types of reporter antigens: (1) new antigen (keyhole limpet hemocyanin (KLH)), (2) recall protein antigen (tetanus), and (3) viral antigen (cytomegalovirus (CMV)). Changes in the number of antigens will be used to determine immune response. | Pre-study, Days 5, 8, 15, 29, 36, 43, and 57. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Curti, MD | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Cancer Center | Portland | Oregon | 97213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24177180 | Derived | Curti BD, Kovacsovics-Bankowski M, Morris N, Walker E, Chisholm L, Floyd K, Walker J, Gonzalez I, Meeuwsen T, Fox BA, Moudgil T, Miller W, Haley D, Coffey T, Fisher B, Delanty-Miller L, Rymarchyk N, Kelly T, Crocenzi T, Bernstein E, Sanborn R, Urba WJ, Weinberg AD. OX40 is a potent immune-stimulating target in late-stage cancer patients. Cancer Res. 2013 Dec 15;73(24):7189-7198. doi: 10.1158/0008-5472.CAN-12-4174. Epub 2013 Oct 31. |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D008223 | Lymphoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Cohort 2 anti-OX40 | Drug | .4 mg/kg anti-OX40 on days 1, 3, and 5 |
|
| Cohort 3 anti-OX40 | Drug | 2.0 mg/kg anti-OX40 on days 1, 3, and 5 |
|
| Tetanus Day 29 | Biological | Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29 |
|
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| Tetanus Day 1 | Biological | Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1. |
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| KLH Day 1 | Biological | 1 mg KLH in 1 cc diluent subcutaneously on Day 1. |
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| KLH Day 29 | Biological | 1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29. |
|
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| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |