Vaccine Therapy or Observation in Treating Patients With Nasopharyngeal Cancer at High Risk for Recurrence - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00112541

Purpose

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

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

Condition	Intervention	Phase
Head and Neck Cancer	Biological: LMP-2:340-349 peptide vaccine Biological: LMP-2:419-427 peptide vaccine Biological: incomplete Freund's adjuvant Procedure: adjuvant therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase I/II Trial of Latent Membrane Protein (LMP) - 2 Immunization for the Assessment of the Natural History and the Immunization-Induced Immunological Response in Patients at High Risk for Recurrence of Anaplastic Nasopharyngeal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Freund's adjuvant

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response to MHC class I, HLA-A*-1101 restricted T cell epitopes of EBV encoded LMP-2 [ Designated as safety issue: No ]
Response to MHC class I, HLA-A*-2404 restricted T cell epitopes of EBV encoded LMP-2 [ Designated as safety issue: No ]
Positive immune response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Designated as safety issue: Yes ]
Clinical activity [ Designated as safety issue: No ]
Surrogate marker [ Designated as safety issue: No ]

Estimated Enrollment:	99
Study Start Date:	April 2005

Detailed Description:

OBJECTIVES:

Primary

Determine the efficacy of adjuvant vaccine therapy comprising either Epstein-Barr virus (EBV)-encoded latent membrane protein (LMP)-2: 340-349 peptide or EBV -encoded LMP-2: 419-427 peptide emulsified in Montanide ISA-51, in terms of inducing CD8+ T-cell responses, in patients with anaplastic nasopharyngeal carcinoma at high risk for recurrence.

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 older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 meet the above AST and ALT criteria

Renal

Creatinine ≤ 2.0 mg/dL

Immunologic

HIV negative
No known hypersensitivity to study agents
No known immunodeficiency disease
No active primary or secondary immunodeficiency
No autoimmune disease
No active systemic infection

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 1 month since prior systemic biologic therapy in the adjuvant or metastatic setting

Chemotherapy

See Disease Characteristics
At least 1 month since prior systemic chemotherapy in the adjuvant or metastatic setting

Endocrine therapy

No concurrent systemic steroid therapy

Radiotherapy

See Disease Characteristics

Surgery

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

Other

Recovered from all prior therapy (alopecia allowed)
At least 1 month since other prior systemic therapy in the adjuvant or metastatic setting
More than 3 weeks since prior systemic therapy for NPC
No other concurrent systemic therapy for NPC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112541

Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Francesco M. Marincola, MD

NIH - Warren Grant Magnuson Clinical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000430681, NCI-04-CC-0118
Study First Received:	June 2, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00112541 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer

Study placed in the following topic categories:

Nasopharyngeal Carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Immunologic Factors
Head and Neck Neoplasms
Adjuvants, Immunologic

Pharyngeal Neoplasms
Freund's Adjuvant
Stomatognathic Diseases
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Recurrence

Additional relevant MeSH terms:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharyngeal Neoplasms
Pharyngeal Diseases
Pharmacologic Actions

Nasopharyngeal Neoplasms
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Nasopharyngeal Diseases
Freund's Adjuvant
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 06, 2009