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
N/A
75 Years
Both
Head and Neck Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival at 3 and 5 years
Safety Issue:
No
Principal Investigator
Giorgio Cortesina, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Universita Degli Studi di Turin
Authority:
Unspecified
Study ID:
CDR0000064500
NCT ID:
NCT00002702
Start Date:
September 1992
Completion Date:
Related Keywords:
- Head and Neck Cancer
- 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
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Mouth Neoplasms
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