APN401 in Treating Patients With Melanoma, Kidney Cancer, Pancreatic Cancer, or Other Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02166255|
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Melanoma Recurrent Pancreatic Cancer Recurrent Renal Cell Cancer Stage III Pancreatic Cancer Stage III Renal Cell Cancer Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma Stage IV Pancreatic Cancer Stage IV Renal Cell Cancer Unspecified Adult Solid Tumor, Protocol Specific||Biological: siRNA-transfected peripheral blood mononuclear cells APN401 Other: laboratory biomarker analysis||Phase 1|
I. To determine the toxicities and establish the maximal tolerated dose (MTD) of APN401.
II. To determine the effects of APN401 on immune response.
I. To document clinical response and survival.
OUTLINE: This is a dose-escalation study.
Patients receive autologous siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes for 1 course in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose-Ranging Study to Assess the Safety and Immunologic Activity of APN401|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Treatment (APN401)
Patients receive autologous siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes.
Biological: siRNA-transfected peripheral blood mononuclear cells APN401
Other Name: APN401
Other: laboratory biomarker analysis
- Maximum tolerated dose of siRNA-transfected peripheral blood mononuclear cells APN401, defined as the dose in which the number of patients with dose limiting toxicity is less than or equal to one out of six [ Time Frame: 14 days ]
- Incidence of adverse events of APN401, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]Adverse events will be categorized by organ system and severity and summarized as frequency counts and percentages.
- Immune response, measured by change in blood Th1-associated cytokines production in response to anti-CD3/28 stimulation or >= tumor antigens post-therapy [ Time Frame: Baseline to week 9 ]Summarized as medians and ranges. The effects of treatment on these markers individually will be analyzed using paired t-tests (possibly after transformation, e.g., logarithmic) or the non-parametric counterpart. Differences between dose levels at particular time points will be analyzed using analysis of variance and 2-sample t-tests, and differences over time will be analyzed using longitudinal methods such as repeated measures. The association between the markers (baseline and changes) and objective response will also be examined.
- Clinical response assessed by RECIST [ Time Frame: Up to 5 years ]Summarized as frequency counts and percentages.
- Progression-free survival [ Time Frame: From the initial infusion to confirmation of progression or death, assessed up to 5 years ]Standard survival analysis techniques using Kaplan Meier methods will be used.
- Overall survival [ Time Frame: From the initial infusion to confirmation of progression or death, assessed up to 5 years ]Standard survival analysis techniques using Kaplan Meier methods will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166255
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Pierre Triozzi||Wake Forest University Health Sciences|