Interleukin-2 Gene or Methotrexate in Treating Patients With Recurrent or Refractory Stage III or Stage IV Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent metastatic squamous neck cancer with occult primary, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory stage III or IV squamous cell carcinoma of the head and neck Failed first line chemotherapy for advanced or recurrent disease Measurable disease accessible to direct injection Tumor must not be involving major blood vessels or obstructing the airway PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: No active liver disease Transaminases no greater than 3 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No respiratory disease sufficient enough to influence oxygenation of arterial blood Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception At least 2 weeks since prior infection No concurrent infection No active or clinically relevant viral illness No clinical condition (e.g., effusions or ascites) that would preclude methotrexate administration No known hypersensitivity to antimetabolite chemotherapeutic agents No rheumatic or autoimmune disease No other concurrent malignancies requiring treatment PRIOR CONCURRENT THERAPY: Biologic therapy: No prior antitumor therapy with recombinant DNA products including viral based gene therapy or bacterial plasmids At least 28 days since prior immunotherapy and at least 14 days since complete recovery At least 14 days since complete recovery from prior antiviral therapy No concurrent hematopoietic growth factors (filgrastim (G-CSF) or sargramostim (GM-CSF)) No concurrent recombinant interleukin-2 therapy Prior G-CSF or GM-CSF adjunct therapy allowed Chemotherapy: See Disease Characteristics At least 28 days since prior chemotherapy and at least 14 days since complete recovery No prior methotrexate Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 28 days since prior radiotherapy and at least 14 days since complete recovery Surgery: No planned surgical resection Other: At least 14 days since complete recovery from prior antibiotic therapy No concurrent high dose nonsteroidal antiinflammatories or immunosuppressive drugs At least 30 days since prior investigational drugs
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute