Cyclophosphamide, TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive and/or Refractory Solid Malignancies
|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: NCT02224599|
Recruitment Status : Active, not recruiting
First Posted : August 25, 2014
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Progressive Solid Malignancies Refractory Solid Malignancies Cancer||Biological: TAPA-pulsed DC vaccine Drug: Cyclophosphamide Pill Drug: Imiquimod Topical Cream||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Low-Dose Cyclophosphamide, Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Imiquimod, in Patients With Progressive and/or Refractory Solid Malignancies|
|Actual Study Start Date :||July 28, 2017|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
Experimental: CYP, TAPA-pulsed DC vaccine, Imiquimod
TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream
Biological: TAPA-pulsed DC vaccine
Subjects will given the vaccine which contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly.
Drug: Cyclophosphamide Pill
Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle.
Other Name: Cytoxan®, Neosar®
Drug: Imiquimod Topical Cream
Topical Imiquimod Cream will be applied after vaccination.
Other Name: Aldara Cream, Zyclara
- Adverse events due to administration of TAPA-Pulse DC Vaccine [ Time Frame: Continuous for 45 days after the first dose. ]Grade, causality, start/stop dates (duration), resolutions for adverse events will be monitored and recorded.
- Immune Response [ Time Frame: Days -7, 22 and 45 ]The response of T-cells present in the peripheral blood mononuclear cells (PBMCs) population to the peptides used to pulse a patient's dendritic cell vaccine is evaluated by measuring the expression of Th1/CTL-type cytokines (IFN-γ and/or TNF-α and/or IL-17) by a standard ELI-Spot assay using 500,000 PBMCs per experimental replicate and a minimum of 3 experimental replicates for each stimulation. The results are expressed as the average number of spots obtained from the stimulation of 500,000 PBMCs
- Positive DTH Skin tests with relevant TAPA [ Time Frame: Days -7, 22 and 45 ]DTH skin test will be performed on subject's forearm or within 5 cm from the site of prior DC vaccination, if possible
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224599
|United States, Texas|
|San Antonio, Texas, United States, 78240|
|Principal Investigator:||TBD TBD|