LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Platinum-Resistant Ovarian Carcinoma
- Bone Sarcoma
- Dedifferentiated Chondrosarcoma
- Giant Cell Tumor of Bone
- Malignancy in Giant Cell Tumor of Bone
- Thyroid Gland Anaplastic Carcinoma
- Malignant Solid Neoplasm
- Ovarian Carcinosarcoma
- Poorly Differentiated Thyroid Gland Carcinoma
- Soft Tissue Sarcoma
- Recurrent Osteosarcoma
- Recurrent Ovarian Carcinoma
- Refractory Osteosarcoma
- Undifferentiated High Grade Pleomorphic Sarcoma of Bone
- Thyroid Gland Squamous Cell Carcinoma
- 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