Autologous T Cells and Cyclophosphamide in Treating Patients With Soft Tissue Sarcoma That is Metastatic or Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT01477021|
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adult Liposarcoma Adult Synovial Sarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma||Drug: cyclophosphamide Biological: NY-ESO-1-specific T cells Other: laboratory biomarker analysis||Phase 1|
I. Assess the feasibility, safety and toxicity of treating patients with NY-ESO-1 specific cellular adoptive immunotherapy in myxoid/round cell liposarcoma (MRCL) and synovial sarcoma patients receiving autologous cluster of differentiation (CD)8+ NY-ESO-1 specific T cells following cyclophosphamide conditioning.
I. Evaluate the antitumor effect and persistence of adoptively transferred CD8+ antigen-specific cytotoxic T lymphocyte (CTL) lines following cyclophosphamide conditioning.
Patients receive cyclophosphamide intravenously (IV) on days -3 and -2. Patients receive NY-ESO-1-specific T cells IV on day 0.
After completion of study treatment, patients are followed up for 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study To Determine the Feasibility of Using Autologous NY-ESO-1 Specific CD8+ T Cells For the Treatment of Patients With Advanced Myxoid/ Round Cell Liposarcoma and Synovial Sarcoma.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2013|
Experimental: Treatment (NY-ESO-1 specific CD8+ T cells)
Patients receive cyclophosphamide IV on days -3 and -2. Patients receive NY-ESO-1-specific T cells IV on day 0.
Biological: NY-ESO-1-specific T cells
Other: laboratory biomarker analysis
- Incidence of treatment-related toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 10 weeks ]Patients will be monitored for treatment-related toxicities. All unexpected grade 3, 4, and 5 toxicities will be reported descriptively.
- Antitumor efficacy as determined by CT scan [ Time Frame: After week 8 ]Radiographic imaging and clinical assessment of residual disease will be compared with pre-infusion assessment. A complete response (CR) will be defined as total regression of all tumor, a partial response (PR) as 30% or greater decrease in the sum of the longest diameter of target lesions and progressive disease (PD) as 20% increase in the sum of the longest diameter of target lesions (RECIST criteria).
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): NCT01477021
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Seth Pollack||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|