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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00646 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Kite, A Gilead Company | INDUSTRY |
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This phase I trial studies the side effects and best dose of autologous dendritic cells in treating patients with metastatic kidney cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of dendritic cell (DC)-AdGM carbonic anhydrase IX (CAIX) administered by intradermal injections at study doses and schedule.
SECONDARY OBJECTIVES:
I. To evaluate clinical antitumor effects following study treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Parameters include objective response (complete response [CR], partial response [PR]), duration of response in patients with objective response, and time to disease progression.
II. To evaluate immune responses to DC-AdGMCAIX vaccination by enzyme-linked immunospot (ELISpot) for numeric determination of CAIX specific T cells in blood.
III. To evaluate immune responses to DC-AdGMCAIX vaccination by cytokine profiling of T cell culture supernatants for characterization of the immune response in subjects with demonstrated immune activation may be performed.
IV. To evaluate immune responses to DC-AdGMCAIX vaccination by anti-sargramostim (GM-CSF) antibody response.
V. To evaluate tumor biopsies for immune cell infiltrates.
OUTLINE: This is a dose-escalation study.
Patients receive AdGMCAIX-transduced autologous dendritic cells intradermally (ID) on days 1, 15, and 29.
After completion of study treatment, patients are followed up every 2-3 months for at least 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (autologous dendritic cells) | Experimental | Patients receive AdGMCAIX-transduced autologous dendritic cells ID on days 1, 15, and 29. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdGMCAIX-transduced autologous dendritic cells | Biological | Given ID |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events including all grade 3 and grade 4 adverse events regardless of causality, treatment-related adverse events, dose limiting toxicities (DLT), and adverse events leading to discontinuation of study treatment | Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 | Up to day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| CAIX-specific immune response | Measured by ELISpot analysis of T cells from blood and cytokine profiling in T cell cultural supernatants. | Up to 3 years |
| Objective response (CR, PR) according to RECIST guideline version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Drakaki, MD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32925563 | Derived | Faiena I, Comin-Anduix B, Berent-Maoz B, Bot A, Zomorodian N, Sachdeva A, Said J, Cheung-Lau G, Pang J, Macabali M, Chodon T, Wang X, Cabrera P, Kaplan-Lefko P, Chamie K, Belldegrun AS, Pantuck AJ, Drakaki A. A Phase I, Open-label, Dose-escalation, and Cohort Expansion Study to Evaluate the Safety and Immune Response to Autologous Dendritic Cells Transduced With AdGMCA9 (DC-AdGMCAIX) in Patients With Metastatic Renal Cell Carcinoma. J Immunother. 2020 Nov/Dec;43(9):273-282. doi: 10.1097/CJI.0000000000000336. |
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| therapeutic autologous dendritic cells | Biological | Given ID |
|
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| laboratory biomarker analysis | Other | Correlative studies |
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| Up to 3 years |
| Duration of progression-free survival | Up to 3 years |
| Clinical benefit rate (CR, PR, and SD) greater than or equal to 12 weeks | Up to 3 years |
| Disease response (CR, PR, stable disease [SD], and progressive disease [PD]) according to RECIST guideline version 1 | Up to 3 years |
| Duration of response according to RECIST guideline version 1 | Up to 3 years |
| Time to disease progression | Up to 3 years |
| 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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