T-cell Based Immunotherapy for of Melanoma

Status Completed

Clinical Trial Summary

The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.

Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.

After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Melanoma

Clinical Trial Details

NCT number	NCT00937625
Study type	Interventional
Source	Herlev Hospital
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	June 2009
Completion date	January 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT03979872` - Risk Information and Skin-cancer Education for Undergraduate Prevention	N/A
Recruiting	`NCT04986748` - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Recruiting	`NCT05707286` - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting	`NCT05470283` - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	Phase 1
Recruiting	`NCT05077137` - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy	Phase 1
Active, not recruiting	`NCT02721459` - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma	Phase 1
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting	`NCT05839912` - Excision of Lymph Node Trial (EXCILYNT) (Mel69)	N/A
Recruiting	`NCT04971499` - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma	Phase 1/Phase 2
Recruiting	`NCT05263453` - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation	Phase 2
Active, not recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06413680` - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies	Phase 1/Phase 2
Completed	`NCT03348891` - TNF in Melanoma Patients Treated With Immunotherapy	N/A
Terminated	`NCT03399448` - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)	Phase 1
Completed	`NCT03171064` - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment	Phase 2
Not yet recruiting	`NCT05539118` - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma	Phase 1/Phase 2
Recruiting	`NCT05171374` - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn	`NCT02854488` - Yervoy Pregnancy Surveillance Study