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TIL Therapy for Metastatic Renal Cell Carcinoma

NCT02926053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-11-22

Study results available
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Summary

Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. The TILs are isolated from patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 is administered to support T cell activation and proliferation in vivo.

Recent studies suggest, that TIL therapy works in other cancers than Metastatic Melanoma, including Renal Cell Carcinoma. In this study TIL therapy is administered to patients with metastatic Renal Cell Carcinoma.

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

PROCEDURE

Surgical removal of tumor tissue for T cell production

Surgical removal of \> 1 cm3 tumor tissue chosen with regards to high rate of success and to minimize the general risks involved in a surgical procedure.

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.

DRUG

Fludarabine

Fludarabine 25 mg/m2 is administered on day -5 to day -1. Maximum dose of 50 mg per administration.

BIOLOGICAL

TIL infusion

The maximum number of expanded TILs are infused over 30-45 minutes on day 0.

DRUG

Interleukin-2

Interleukin-2 is administered as high-dose bolus infusions (600.000 IU/kg) over a 15 minute period every 8 hours and continuing for up to 5 days (maximum of 15 doses).

Sponsors & Collaborators

  • Inge Marie Svane

    lead OTHER

Principal Investigators

  • Inge M Svane, Prof., MD · Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital, Borgmester Ib Juuls vej 25C, DK-2730

  • Troels H Borch, MD, PhD · Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital, Borgmester Ib Juuls vej 25C, DK-2730

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02926053 on ClinicalTrials.gov