Cyclophosphamide, TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive and/or Refractory Solid Malignancies
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|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
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): NCT02224599
|United States, Texas|
|San Antonio, Texas, United States, 78240|
|Principal Investigator:||TBD TBD|