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Vaccination of renal cell cancer patients with modified vaccinia Ankara delivering the tumor antigen 5T4 (TroVax) alone or administered in combination with interferon-alpha (IFN-alpha): a phase 2 trial.

Abstract
Attenuated vaccinia virus, modified vaccinia Ankara (MVA) has been engineered to deliver the tumor antigen 5T4 (TroVax). MVA-5T4 has been evaluated in an open-label phase 2 trial in metastatic renal cell cancer patients in which the vaccine was administered alone or in combination with interferon-alpha-2b (IFN-alpha). The safety, immunologic, and clinical efficacy of MVA-5T4 with or without IFN-alpha was determined. Twenty-eight patients with metastatic renal cell cancer were treated with MVA-5T4 alone (13) or plus IFN-alpha (15). The 5T4-specific cellular and humoral responses were monitored throughout the study. Clinical responses were assessed by measuring changes in tumor burden by computed tomography or magnetic resonance imaging scan. MVA-5T4 was well tolerated with no serious adverse event attributed to vaccination. Of 23 intent-to-treat patients tested for immune responses postvaccination, 22 (96%) mounted 5T4-specific antibody and/or cellular responses. One patient treated with MVA-5T4 plus IFN-alpha showed a partial response for >7 months, whereas an additional 14 patients (7 receiving MVA-5T4 plus IFN and 7 receiving MVA-5T4 alone) showed periods of disease stabilization ranging from 1.73 to 9.60 months. Median progression free survival and overall survival for all intent-to-treat patients was 3.8 months (range: 1 to 11.47 mo) and 12.1 months (range: 1 to 27 mo), respectively. MVA-5T4 administered alone or in combination with IFN-alpha was well tolerated in all patients. Despite the high frequency of 5T4-specific immune responses, it is not possible to conclude that patients are receiving clinical benefit. The results are encouraging and warrant further investigation.
AuthorsRobert J Amato, William Shingler, Madusha Goonewardena, Jackie de Belin, Stuart Naylor, Jaroslaw Jac, James Willis, Somyata Saxena, Joan Hernandez-McClain, Richard Harrop
JournalJournal of immunotherapy (Hagerstown, Md. : 1997) (J Immunother) Vol. 32 Issue 7 Pg. 765-72 (Sep 2009) ISSN: 1537-4513 [Electronic] United States
PMID19561532 (Publication Type: Clinical Trial, Phase II, Journal Article)
Chemical References
  • Antibodies, Viral
  • Cancer Vaccines
  • Interferon-alpha
  • TroVax
  • Vaccines, DNA
  • Interferon-gamma
Topics
  • Adult
  • Aged
  • Anemia (chemically induced)
  • Antibodies, Viral (blood)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, immunology, therapeutic use)
  • Cancer Vaccines (administration & dosage, genetics, immunology)
  • Carcinoma, Renal Cell (drug therapy, immunology, pathology)
  • Drug Delivery Systems (methods)
  • Enzyme-Linked Immunosorbent Assay
  • Fatigue (chemically induced)
  • Female
  • Fever (chemically induced)
  • Humans
  • Interferon-alpha (administration & dosage)
  • Interferon-gamma (immunology)
  • Kidney Neoplasms (drug therapy, immunology, pathology)
  • Lymphopenia (chemically induced)
  • Male
  • Middle Aged
  • Survival Analysis
  • Treatment Outcome
  • Vaccination (adverse effects, methods)
  • Vaccines, DNA
  • Vaccinia virus (genetics, immunology)

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