Vaccine Enriched, Autologous, Activated T-Cells Directed to Tumor in Patients With Relapsed/Refractory Melanoma

Completed · Phase 1

Conditions studied: Melanoma

In brief

The researchers will investigate if modified T-cells from a patients own system can be utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.

Key facts

Study ID

NCT02482532

Run by

Gary Doolittle

People needed

7

Starts

2016-10-06

Expected to finish

2021-09-13

Last updated by the study team

2022-02-04

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic, surgically unresectable melanoma or newly diagnosed melanoma of any stage, where the patient is unable to receive or complete standard therapy
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2
• Laboratory Values
• absolute neutrophil count > 500 microliters (mcL)
• platelet > 50,000 mcL
• serum aspartate aminotransferase (AST) < 5 x institutional upper limit of normal (IULN)
• total bilirubin < 3 x IULN
• serum creatinine < 3 x IULN
• Pulse oximetry of > 95% on room air.
• Must have recovered from the toxic effects of all prior chemotherapy

You may not qualify if…

• Patients with rapidly progressive disease.
• Patient is currently receiving any investigational drugs
• Current cardiomegaly or bilateral pulmonary infiltrates on chest radiograph, pulmonary metastatic lesions are allowed
• Patients must not have tumor in a location where enlargement could cause airway obstruction
• Patient is pregnant or lactating
• History of hypersensitivity reactions to murine protein-containing products.
• Currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporin
• Received any tumor vaccines within previous six weeks
• Known hypersensitivity to rat monoclonal antibodies
• History of severe allergic reaction to Hepatitis B vaccine, Polio vaccine or Tetanus, Diphtheria, Pertussis vaccine (DTP, Tdap, DT or Td).
• Allergy to baker's yeast or other components of the vaccines.
• History of allergy to the antibiotics Neomycin, Streptomycin or Polymyxin B
• History of coma, long/multiple seizures within 7 days after DTP or Tdap, unless a cause other than the vaccine was indicated.
• Melanoma involvement of the central nervous system
• Chemotherapy given within the last 28 days
• Presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)

Where it is running

• KU Cancer Center — Fairway, Kansas, United States

Full record on ClinicalTrials.gov

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