Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma
|ClinicalTrials.gov Identifier: NCT01807182|
Recruitment Status : Active, not recruiting
First Posted : March 8, 2013
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion With Cyclophosphamide and Fludarabine for Patients With Metastatic Melanoma|
|Actual Study Start Date :||August 20, 2013|
|Actual Primary Completion Date :||August 18, 2017|
|Estimated Study Completion Date :||August 18, 2018|
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
- 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.
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): NCT01807182
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Sylvia Lee||Fred Hutch/University of Washington Cancer Consortium|