Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	75 and under	Other	CNR-9506 EU-95024, NCT00002702

Objectives

1. 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.
2. Compare the response rate in patients treated with these regimens.
3. Determine the local and systemic effects of locoregional IL-2 on host-tumor interaction and immune properties in these patients.

Entry 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

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

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

Expected Enrollment

A total of 260 patients (130 per treatment arm) will be accrued for this study.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

European Institute of Oncology

Giorgio Cortesina, MD, Protocol chair		Ph: 39-011-663-6688

Italy
	Bari
	Universita Degli Studi di Bari
		G. Cervellera, MD	Ph:  39-080-5478-660
	Cagliari
	Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
		P. Puxeddu, MD	Ph:  39-070-5109-6253
	Ferrara
	Universita di Ferrara
		C. Calearo, MD	Ph:  39-0532-209-296
			Email: ccv@dns.unife.it
	Florence
	Universita Degli Studi di Florence - Policlinico di Careggi
		O. Fini-Storchi, MD	Ph:  39-55-411739
	Turin
	Azienda Sanitaria Ospedaliera Ordine Mauriziano
		G. Forni, MD	Ph:  39-11-508-1111
		Pietro Gabriele, MD	Ph:  39-011-508-2461
	Universita di Torino
		G. Valente, MD	Ph:  39-011-670-5955
	Vicenza
	Ospedale San Bortolo
		C. Curioni, MD	Ph:  39-444-993-906

Registry Information
Official Title		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
Trial Start Date		1992-09-01
Registered in ClinicalTrials.gov		NCT00002702
Date Submitted to PDQ		1995-11-28
Information Last Verified		2007-02-13

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