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

NCT02482532 | Completed Phase 1 DMC

• 1 other identifier: Mel-2012-01-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

Melanoma; metastatic; relapsed; refractory

Outcome Measures

Primary Outcomes (3)

• Measurement of infusion related adverse events to evaluate the safety of infused T-cells

  To evaluate the safety of autologous, receptor-transduced, activated T-cells, enriched for vaccine-specific cytotoxic T-lymphocytes (tvs-CTL)

  4 weeks

• PCR measurement of retroviral construct to measure persistence of infused T-cells

  To evaluate how long the infused T-cells remain in the blood stream

  4 weeks

• Measurement of replication competent retrovirus to evaluate the safety of infused T-cells

  To evaluate the safety of autologous, receptor-transduced, activated T-cells, enriched for vaccine-specific cytotoxic T-lymphocytes (tvs-CTL)

  4 weeks

Secondary Outcomes (3)

• PCR measurement of retroviral construct to measure the expansion of infused T-cells

  12 months

• PCR measurement of retroviral construct to compare frequency of peripheral tvs-CTL population pre-infusion vs post-revaccination

  12 months

• Imaging studies to measure tumor response

  10 weeks

Study Arms (1)

tvs-CTL Vaccine

EXPERIMENTAL

Infusion of activated T-cells generated from a patient's own peripheral blood mononuclear cells.

Biological: tvs-CTL Vaccine

Interventions

tvs-CTL Vaccine BIOLOGICAL

autologous, 14g2a.zeta chimeric receptor transduced, activated T-cells, enriched for vaccine specific cytotoxic T-lymphocytes (tvs-CTL)

tvs-CTL Vaccine

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gary Doolittle: lead

Study Sites (1)

KU Cancer Center

Fairway, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Recurrence

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Gary Doolittle, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 26, 2015
• Study Start: October 6, 2016
• Primary Completion: October 10, 2019
• Study Completion: September 13, 2021
• Last Updated: February 4, 2022

Record last verified: 2021-11

Locations

US (1)