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

NCT ID: NCT00002702

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1992-09-30

Brief Summary

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.

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.

Conditions

Head and Neck Cancer

Keywords

stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; tongue cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

adjuvant therapy

Intervention Type: PROCEDURE

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Principal Investigators

Giorgio Cortesina, MD

Role: STUDY_CHAIR

Universita Degli Studi di Turin

Locations

Universita Degli Studi di Bari

Bari, , Italy

Site Status: RECRUITING

Cattedra di Oncologia Medica - Universita degli Studi di Cagliari

Cagliari, , Italy

Site Status: RECRUITING

Universita di Ferrara

Ferrara, , Italy

Site Status: RECRUITING

Universita Degli Studi di Florence - Policlinico di Careggi

Florence, , Italy

Site Status: RECRUITING

Universita di Torino

Turin, , Italy

Site Status: RECRUITING

Azienda Sanitaria Ospedaliera Ordine Mauriziano

Turin, , Italy

Site Status: RECRUITING

Ospedale San Bortolo

Vicenza, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

G. Cervellera, MD

Role: primary

P. Puxeddu, MD

Role: primary

C. Calearo, MD

Role: primary

O. Fini-Storchi, MD

Role: primary

G. Valente, MD

Role: primary

G. Forni, MD

Role: primary

C. Curioni, MD

Role: primary

Other Identifiers

CNR-9506

Identifier Type: -

Identifier Source: secondary_id

EU-95024

Identifier Type: -

Identifier Source: secondary_id

CDR0000064500

Identifier Type: -

Identifier Source: org_study_id