Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx

Overview

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether giving interleukin-2 with surgery and radiation therapy is more effective than surgery and radiation therapy alone. PURPOSE: This randomized phase III trial is studying surgery and radiation therapy alone to see how well they work compared to surgery, radiation therapy, and interleukin-2 in treating patients with cancer of the mouth or oropharynx.

Full Title of Study: “Multicentre Randomised Trial of Inductive and Adjuvant Perilymphatically Injected Proleukin (rlL-2) in The Treatment of Operable Primary Squamous Cell Carcinoma of The Oral Cavity and Oropharynx”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Primary Purpose: Treatment

Detailed Description

OBJECTIVES: – Compare the disease-free and overall survival in patients with previously untreated squamous cell carcinoma of the oral cavity or oropharynx treated with resection with or without and neoadjuvant and adjuvant perilymphatic interleukin-2 (IL-2) and radiotherapy. – Compare the response rate in patients treated with these regimens. – Determine the local and systemic effects of locoregional IL-2 on host-tumor interaction and immune properties in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and tumor stage (T2, N0-2 vs T2, N3 or T3-4, N0-3). Patients are randomized to 1 of 2 treatment arms. – Arm I: Patients undergo induction comprising interleukin-2 (IL-2) via perilymphatic injections to the ipsilateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5 and 8-12. Within 10 days after the last IL-2 injection, patients undergo en bloc resection of the primary tumor and corresponding lymphatic drainage area and pre-study margins. Beginning within 4 weeks after surgery, patients with T2, N0-3 disease but with pathohistological evidence of node invasion or capsular rupture of node metastasis or T3-4, N0-3 disease undergo adjuvant radiotherapy 5 days a week for 4.5-6.5 weeks. Beginning within 4 weeks after surgery or radiotherapy (if applicable), patients receive adjuvant IL-2 via perilymphatic injections to the contralateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5. Adjuvant IL-2 continues monthly for at least 1 year in the absence of disease progression. – Arm II: Patients undergo resection and radiotherapy (if eligible) as in arm I. Patients are followed monthly for 1 year and then every 2 months for 2 years. PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study.

Interventions

  • Biological: aldesleukin
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy

Clinical Trial Outcome Measures

Primary Measures

  • Disease-free survival at 3 and 5 years
  • Recurrence/metastasis rate at 3 and 5 years
  • Response rate
  • Local and systemic effects of treatment

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Histologically proven squamous cell carcinoma of the oral cavity or oropharynx – Operable, primary, unilateral, stage T2-4, N0-3, M0 disease – No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection) – No tumor involvement of the following sites: – Pterygopalatine fossa – Carotid artery – Maxillary sinus – Facial skin – Anterior floor of the mouth – Base of the tongue infiltrating more than 1 cm – Measurable or evaluable disease by physical exam and/or noninvasive imaging PATIENT CHARACTERISTICS: Age: – 75 and under Performance status: – ECOG 0-2 OR – Karnofsky 70-100% Life expectancy: – More than 3 months Hematopoietic: – WBC at least 4,000/mm3 – Platelet count at least 60,000/mm3 – Hematocrit at least 30% Hepatic: – Bilirubin normal – Hepatitis B surface antigen negative Renal: – Creatinine normal Cardiovascular: – No congestive heart failure – No uncontrolled hypertension – No coronary artery disease – No serious arrhythmia – No evidence of prior myocardial infarction on ECG (stress test required if in doubt) Other: – HIV negative – No autoimmune disease – No contraindications to pressor agents – No serious infection requiring antibiotics – No other concurrent primary malignancy – Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: – No prior or other concurrent immunotherapy Chemotherapy: – No prior or concurrent chemotherapy Endocrine therapy: – No prior or concurrent hormonal therapy – No concurrent corticosteroids Radiotherapy: – No prior radiotherapy Surgery: – See Disease Characteristics – No prior major organ allografts Other: – No other prior therapy – No other concurrent investigational drugs, agents, or devices – No concurrent nonsteroidal antiinflammatory drugs, ranitidine, cimetidine, or coumarin

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Institute of Oncology
  • Overall Official(s)
    • Giorgio Cortesina, MD, Study Chair, Universita Degli Studi di Turin

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