|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Vaccine Therapy or Observation in Treating Patients With Nasopharyngeal Cancer at High Risk for Recurrence | ||||
| 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 | ||||
| Brief Summary | 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. |
||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are assigned to 1 of 3 treatment groups according to HLA typing.
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. |
||||
| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | 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 Measure † | Safety [ Designated as safety issue: Yes ] Clinical activity [ Designated as safety issue: No ] Surrogate marker [ Designated as safety issue: No ] |
||||
| Condition † | Head and Neck Cancer | ||||
| Intervention † | Drug: LMP-2:340-349 peptide vaccine Drug: LMP-2:419-427 peptide vaccine Drug: incomplete Freund's adjuvant Procedure: adjuvant therapy |
||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 99 | ||||
| Start Date † | April 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00112541 | ||||
| Organization ID | CDR0000430681 | ||||
| Secondary IDs †† | NCI-04-CC-0118 | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2006 | ||||
| First Received Date † | June 2, 2005 | ||||
| Last Updated Date | October 18, 2008 | ||||