Therapy for Progressive and/or Refractory Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02223312|
Recruitment Status : Recruiting
First Posted : August 22, 2014
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Hematologic Malignancies||Biological: TAPA-pulsed DC vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 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 Low Dose GM-CSF, in Patients With Progressive and/or Refractory Hematologic Malignancies|
|Actual Study Start Date :||July 28, 2017|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||January 31, 2019|
Experimental: TAPA-pulsed DC vaccine
The subject will take low-dose cyclophosphamide by mouth for 5 days starting 7 days prior to the vaccine cycle. The vaccine contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered SQ with low-dose GM-CSF following the low-dose cyclophosphamide cycle. A total of six (6) cycles of cyclophosphamide and six (6) DC vaccines cycles will be administered alternating every 14 days.
Biological: TAPA-pulsed DC vaccine
A cycle of low-dose cyclophosphamide (100mg/day) by mouth for 5 days starting seven 7 days prior to the DC vaccine cycle to reduce Treg activity. Low-dose cyclophosphamide will be taken every 14 days for six 6 cycles. A total of 6 vaccines containing 1 x 10^7 TAPA-pulsed DC will be administered SQ every 14 days. The DC vaccine is given on Day 1 of the DCV cycle plus low-dose GM-CSF 50mcg/day SQ x 5 days (Day 1 to Day 4). GM-CSF is administered for 5 days to increase monocyte production and dendritic cell precursors to optimize immune responses.
- Number of adverse events that occur due to toxicity of low-dose CYP followed by TAPA-pulsed DC therapy and low-dose GM-CSF administration [ Time Frame: Every 7 days ]
- Immunological efficacy as indicated by T-cell cytokine levels [ Time Frame: up to 5 months ]
- Immunological efficacy as determined by a positive delayed type hypersensitivity (DTH) skin test [ Time Frame: up to 5 months ]DTH skin test will be performed 8-10 days before vaccine administration. DTH response will be evaluated again at days 28 and 70 of the trial as well as 14 and 60 days after the trial has ended.
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): NCT02223312
|Contact: Diane D Nguyen, DOfirstname.lastname@example.org|
|Contact: Scott Dahlbeck, MD, PharmDemail@example.com|
|United States, Texas|
|Oncology San Antonio||Recruiting|
|San Antonio, Texas, United States, 78235|
|Contact: Rosalinda Ferniz, RN 210-842-2147 firstname.lastname@example.org|
|Contact: Syed Raza, MD 210-922-5556 email@example.com|
|Principal Investigator:||Syed Raza, MD||Oncology San Antonio|