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Vaccine Therapy in Treating Patients With Nasopharyngeal Cancer at High Risk for Recurrence After Standard Therapy - Article


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Nasopharyngeal Cancer


Clinical Trial: Vaccine Therapy in Treating Patients With Nasopharyngeal Cancer at High Risk for Recurrence After Standard Therapy

This study is currently recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with nasopharyngeal cancer at high risk for recurrence after standard therapy.

Condition Treatment or Intervention Phase
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer
 Drug: EBV-specific cytotoxic T-lymphocytes
 Drug: LMP2A-specific cytotoxic T-lymphocytes
 Drug: Montanide ISA-51
 Procedure: adjuvant therapy
 Procedure: biological response modifier therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: non-tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase I
Phase II

MedlinePlus related topics:  Head and Neck Cancer;   Throat Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Adjuvant Vaccine Therapy Comprising Either Epstein-Barr Virus-Encoded Latent Membrane Protein (LMP)-2: 340-349 Peptide or LMP-2: 419-427 Peptide Emulsified in Montanide ISA-51 or Observation Alone in Patients With Anaplastic Nasopharyngeal Carcinoma at High Risk for Recurrence

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine the safety of these regimens in these patients.
  • Determine whether plasma anti-EBV titers parallel the natural history or treatment-induced history of this disease in these patients.
  • Determine whether plasma anti-EBV titers can be used as surrogate markers to monitor the efficacy of these regimens in these patients.

OUTLINE: Patients are assigned to 1 of 3 treatment groups according to HLA typing.

  • Group 1 (HLA-A*1101): Patients receive Epstein-Barr virus (EBV)-encoded latent membrane protein (LMP)-2: 340-349 peptide emulsified in Montanide ISA-51 subcutaneously (SC) once weekly in weeks 1-8.
  • Group 2 (HLA-A*2402)*: Patients receive EBV-encoded LMP-2: 419-427 peptide emulsified in Montanide ISA-51 SC once weekly in weeks 1-8.
  • Group 3 (non HLA-A*1101 and non HLA-A*2402): Patients undergo observation only for at least 12 weeks. NOTE: *Patients who express both HLA-A*1101 and HLA-A*2402 are assigned to group 2.

In groups 1 and 2, treatment repeats every 12 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, immune response is assessed. Patients with no immune response undergo observation. Patients with an objective immune response may receive 2 additional courses of therapy for a maximum of 4 courses (approximately 1 year).

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 42-99 patients (14-33 per treatment group) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed anaplastic nasopharyngeal carcinoma (NPC), meeting 1 of the following criteria at disease onset:
  • Advanced local disease (T3-T4, N0-N1, M0)
  • Nodal disease (T1-T2, N2-N3, M0)
  • Locoregional disease (T3-T4, N2-N3, M0)
  • Completely resected metastatic disease
  • Disease free by physical examination; ear, nose, and throat endoscopy; CT scan of abdomen, chest, neck, and nasal sinuses; and MRI of the head performed within the past 6 weeks
  • Disease controlled by standard surgery OR standard chemotherapy and radiotherapy
  • Completed standard therapy ≥ 3 months before study entry
  • Demonstrates evidence of local control with no histological or radiological evidence of recurrent disease
  • HLA-A*1101- or HLA-A*2042-positive disease* by high resolution molecular testing NOTE: *Patients who do not meet the above HLA typing criteria are assigned to the study observation group

PATIENT CHARACTERISTICS: Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 90,000/mm^3

Hepatic

  • AST and ALT < 3 times normal
  • Bilirubin ≤ 1.6 mg/dL (< 3.0 mg/dL for patients with Gilbert''''s syndrome)
  • Hepatitis B surface antigen negative
  • Hepatitis C positivity allowed provided patients meets the above AST and ALT criteria

Renal

  • Creatinine ≤ 2.0 mg/dL

Immunologic

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics
  • At least 1 month since prior surgery for NPC

Other


Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00112541


Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States; Recruiting
NCI Clinical Studies Support  888-NCI-1937 

Study chairs or principal investigators

Francesco M. Marincola, MD,  Principal Investigator,  NIH - Warren Grant Magnuson Clinical Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000430681; NCI-04-CC-0118
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112541
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07


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October 6, 2008



Page Updated: October 3, 2005
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