Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma
Stage III Skin Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Biological: Therapeutic Tumor Infiltrating Lymphocytes
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion With Cyclophosphamide and Fludarabine for Patients With Metastatic Melanoma|
- Clinical response, assessed using Response Evaluation Criteria in Solid Tumors 1.1 definitions for complete response, partial response, stable disease, and progressive disease [ Time Frame: Up to 24 weeks ]
- In vivo persistence of adoptively transferred T cells following TIL infusion [ Time Frame: Up to 24 weeks ]
- Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 24 weeks ]
- Percent expression of biomarkers [ Time Frame: Up to 24 weeks ]Logistic regression will be used to assess these correlations.
|Actual Study Start Date:||July 26, 2013|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (TIL, combination chemotherapy, aldesleukin)
Patients receive cyclophosphamide IV on days -7 to -6 and fludarabine phosphate IV on days -5 to -1. Patients undergo TIL infusion over 30-60 minutes on day 0 and receive aldesleukin IV every 8 hours on days 1-5 for up to a maximum of 14 doses.
Other Names:Drug: Cyclophosphamide
Other Names:Drug: Fludarabine Phosphate
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesBiological: Therapeutic Tumor Infiltrating Lymphocytes
Undergo TIL infusion
Other Name: Tumor Infiltrating Lymphocytes
I. Examine the anti-tumor efficacy of cellular adoptive immunotherapy in metastatic melanoma patients using autologous tumor-infiltrating lymphocytes with a lymphodepleting conditioning regimen of cyclophosphamide and fludarabine (fludarabine phosphate), and followed by adjuvant high-dose interleukin (IL)-2 (aldesleukin).
I. Determine the in vivo persistence of transferred tumor-infiltrating lymphocytes.
II. Examine the safety of cellular adoptive immunotherapy in melanoma patients using autologous tumor-infiltrating lymphocytes, preceded by a lymphodepleting conditioning regimen of cyclophosphamide and fludarabine, and followed by adjuvant high-dose IL-2.
III. Evaluate for molecular tumor markers and immunohistochemical features that correlate with in vivo persistence and anti-tumor efficacy.
Patients receive cyclophosphamide intravenously (IV) on days -7 to -6 and fludarabine phosphate IV on days -5 to -1. Patients undergo TIL infusion over 30-60 minutes on day 0 and receive aldesleukin IV every 8 hours on days 1-5 for up to a maximum of 14 doses.
After completion of study treatment, patients are followed up at 6, 12, and 24 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807182
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Sylvia M. Lee 206-288-2274 firstname.lastname@example.org|
|Principal Investigator: Sylvia M. Lee|
|Principal Investigator:||Sylvia Lee||Fred Hutch/University of Washington Cancer Consortium|