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||Biological: Aldesleukin Drug: Cyclophosphamide Drug: Fludarabine Phosphate Other: Laboratory Biomarker Analysis Biological: Therapeutic Tumor Infiltrating Lymphocytes||Phase 2|
|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|