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Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery

Recurrent Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
A Phase I/II Trial of Cetuximab in Combination With Interleukin-12 Administered to Patients With Unresectable Primary or Recurrent Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has come back, spread to another place in the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the white blood cells to kill tumor cells. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread Giving recombinant interleukin-12 together with cetuximab may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To find a safe and tolerable interleukin (IL)-12 (recombinant interleukin-12) dose for use in combination with cetuximab in patients with squamous cell carcinoma of the head and neck. (Phase I) II. To determine the response rate to the combination of IL-12 and cetuximab. (Phase II) SECONDARY OBJECTIVES: I. To characterize the immunologic effects of IL-12 when administered in combination with cetuximab. OUTLINE: This is a phase I, dose-escalation study of recombinant IL-12 followed by a phase II study. Patients receive cetuximab intravenously (IV) over 1-2 hours on day 1 and recombinant interleukin-12 subcutaneously (SC) on days 2 and 5 beginning in course 2. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving clinical response or stable disease may continue with therapy until disease progression. After completion of study treatment, patients are followed up for 1 year. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Recurrence
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Unresectable Head and Neck Squamous Cell Carcinoma
Clinical Trial Details
NCT number NCT01468896
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date October 26, 2011
Completion date March 7, 2025
View Details
See also
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