Status:
COMPLETED
PEG-interferon Alfa-2b in Treating Patients With Stage II, Stage III, or Stage IV Head and Neck Cancer That Can Be Removed By Surgery
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: SCH 54031 (PEG-interferon alfa-2b) may interfere with the growth of tumor cells and slow the growth of head and neck cancer. It may also stop the growth of head and neck cancer by blocking ...
Detailed Description
OBJECTIVES: Primary * Determine the antiangiogenic effects of PEG-interferon alfa-2b, in terms of pre- and post-treatment levels of microvessel density (MVD), endothelial cell apoptosis, vascular en...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Stage II, III, or IV disease
- One of the following primary tumor sites:
- Oral cavity
- Oropharynx
- Hypopharynx
- Larynx
- Resectable disease
- Scheduled to undergo surgery as primary treatment
- Distant metastases or a second primary tumor allowed provided tumor deemed resectable by the surgeon
- No squamous cell carcinoma of the nasopharynx or skin
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- White Blood Cells (WBC) \> 3,000/mm\^3
- Platelet count ≥ 150,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Transfusion and/or epoetin alfa support allowed provided it is given ≥ 1 week before study entry AND the patient is stable
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- serum glutamic pyruvic transaminase (SGPT) ≤ 5 times ULN
- Creatinine \< 1.5 times ULN
- No hemolytic anemia
- No hemoglobinopathies (e.g., thalassemia)
- No prior or current ascites
- No bleeding varices
- No other evidence of decompensated liver disease
- No symptomatic ischemic heart disease
- No symptomatic congestive heart failure
- No other uncontrolled heart condition
- No chronic obstructive pulmonary disease
- No documented pulmonary hypertension
- No other chronic pulmonary disease
- No known HIV positivity
- No AIDS-related illness
- No active uncontrolled infection
- No immunologically mediated disease, including any of the following:
- Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- Rheumatoid arthritis
- Idiopathic thrombocytopenia purpura
- Systemic lupus erythematosus
- Autoimmune hemolytic anemia
- Scleroderma
- Severe psoriasis
- No Central Nervous System (CNS) trauma
- No confusion or disorientation
- No active seizure disorders requiring medication
- No spontaneous encephalopathy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No pre-existing uncontrolled thyroid abnormality
- No poorly controlled diabetes mellitus
- No history of major psychiatric illness that would prelude giving informed consent
- No nonmalignant systemic disease that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior biologic therapy and recovered
- More than 4 weeks since prior chemotherapy and recovered
- More than 4 weeks since prior radiotherapy and recovered
- More than 4 weeks since prior surgery
- No prior interferon
- No other concurrent immunotherapy
- No concurrent chemotherapy
- No concurrent hormonal antineoplastic therapy
- No concurrent systemic corticosteroids
- No concurrent radiotherapy
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00276523
Start Date
February 1 2004
End Date
March 1 2006
Last Update
October 31 2012
Active Locations (1)
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1
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009