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

Sponsor:	European Institute of Oncology
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002702

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Biological: aldesleukin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Oral Cancer Surgery

Drug Information available for: Aldesleukin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival at 3 and 5 years [ Designated as safety issue: No ]
Recurrence/metastasis rate at 3 and 5 years [ Designated as safety issue: No ]
Response rate [ Designated as safety issue: No ]
Local and systemic effects of treatment [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	September 1992

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.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002702

Locations

Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano	Recruiting
Turin, Italy, 10128
Contact: G. Forni, MD 39-11-508-1111
Cattedra di Oncologia Medica - Universita degli Studi di Cagliari	Recruiting
Cagliari, Italy, 09042
Contact: P. Puxeddu, MD 39-070-5109-6253
Ospedale San Bortolo	Recruiting
Vicenza, Italy, 36100
Contact: C. Curioni, MD 39-444-993-906
Universita di Torino	Recruiting
Turin, Italy, 10126
Contact: G. Valente, MD 39-011-670-5955
Universita Degli Studi di Florence - Policlinico di Careggi	Recruiting
Florence, Italy, 50134
Contact: O. Fini-Storchi, MD 39-55-411739
Universita di Ferrara	Recruiting
Ferrara, Italy, 44100
Contact: C. Calearo, MD 39-0532-209-296 ccv@dns.unife.it
Universita Degli Studi di Bari	Recruiting
Bari, Italy, 70124
Contact: G. Cervellera, MD 39-080-5478-660

Sponsors and Collaborators

European Institute of Oncology

Investigators

Study Chair:

Giorgio Cortesina, MD

Universita Degli Studi di Turin

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000064500, CNR-9506, EU-95024
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002702 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009