Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Dedifferentiated Chondrosarcoma
  • Bone Sarcoma
  • Giant Cell Tumor of Bone
  • Malignancy in Giant Cell Tumor of Bone
  • Malignant Solid Neoplasm
  • Ovarian Carcinosarcoma
  • Thyroid Gland Anaplastic Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Poorly Differentiated Thyroid Gland Carcinoma
  • Thyroid Gland Squamous Cell Carcinoma
  • Soft Tissue Sarcoma
  • Recurrent Osteosarcoma
  • Recurrent Ovarian Carcinoma
  • Refractory Osteosarcoma
  • Undifferentiated High Grade Pleomorphic Sarcoma of Bone
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 16 years and 70 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To evaluate efficacy using objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in each cohort. SECONDARY OBJECTIVES: I. Determine the disease control rate (DCR) within and across cohorts. II. Determine the duration of respons...

PRIMARY OBJECTIVE: I. To evaluate efficacy using objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in each cohort. SECONDARY OBJECTIVES: I. Determine the disease control rate (DCR) within and across cohorts. II. Determine the duration of response (DOR). III. Determine progression-free survival (PFS) and overall survival (OS). IV. Further characterize the safety profile of adoptive cell therapy with tumor infiltrating lymphocytes (TIL) across multiple tumor types. EXPLORATORY OBJECTIVES: I. Establish duration of tumor-infiltrating lymphocyte (TIL) persistence. II. Compare the molecular and immunological features of tumors before and after TIL therapy. III. Prospectively evaluate the existing immunotherapy response criteria (immune-related [ir]RECIST) as the best response assessment tool for TIL therapy among a diverse group of solid tumors. IV. To investigate TIL attributes (CD8 percentage [%], CD27 and CD28 expression) and correlation with response to therapy. V. Assess tumor marker (CA-125) response in patients who produce this tumor marker. VI. To assess Health-Related Quality of Life (HRQOL). OUTLINE: Patients are assigned to 1 of 2 cohorts. THYROID CANCER COHORT: Patients receive cyclophosphamide intravenously (IV) over 2 hours on days -7 and -6, fludarabine IV over 30 minutes daily on days -5 to -1, autologous tumor infiltrating lymphocytes LN-145 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses. OVARIAN CANCER, OSTEOSARCOMA, OR OTHER BONE AND SOFT TISSUE SARCOMAS COHORT: Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine IV over 30 minutes daily on days -5 to -1, LN-145-S1 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses. After completion of study treatment, patients are followed up at 18 weeks, 6, 9, 12, 18 and 24 months, then every 3 months for at least 3 years.

Tracking Information

NCT #
NCT03449108
Collaborators
  • Iovance Biotherapeutics, Inc.
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Amir A Jazaeri M.D. Anderson Cancer Center