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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002702
First Posted: January 27, 2003
Last Update Posted: August 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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 3

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


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

Primary Outcome 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002702


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

ClinicalTrials.gov Identifier: NCT00002702     History of Changes
Other Study ID Numbers: CDR0000064500
CNR-9506
EU-95024
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: August 26, 2013
Last Verified: February 2011

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
tongue cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents


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