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Home > "S" Clinical Trials Conditions > Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck  Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: This is a randomized, Phase II controlled, dose-finding study of subcutaneous pegylated interferon (SCH 54031) in patients with surgically resectable squamous cell carcinoma of the head and neck. Patients will be randomized in a 1:1:1:1 fashion to receive no treatment, or SCH 54031 at .5 mg/kg, 2.5 mg/kg or 5 mg/kg subcutaneously each week for 4 weeks prior to surgery. (Patients randomized to receive no treatment may undergo surgery at any time within 4 weeks following randomization). A baseline tumor biopsy will be obtained after randomization and before beginning treatment. Tumor specimens will also be obtained at time of surgery. Tumor specimens will be subjected to molecular analysis to determine the biologic activity of SCH 54031. Patients will receive 4 weeks (4 injections) of SCH 54031 administered sub cutaneously each week prior to scheduled surgery or definitive treatment. All patients will receive routine follow-up care after surgery. The schedule of this care will be determined by the physician.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Factorial Assignment, Pharmacodynamics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Histologically-confirmed stage II, III, or IV squamous cell carcinoma of the head and neck. - Eligible sites are oral cavity, oropharynx, hypopharynx, larynx. Ineligible sites are nasopharynx, skin. - Age >= 18 years - Patient with resectable tumor scheduled to undergo surgery as the primary treatment. - ECOG Performance Status of <= 2. - Laboratory values (performed within 14 days prior to administration of SCH 54031): * White blood cell count greater than 3.0 x 10**9/L * Platelet count greater than or equal to 150 x 10**9/L; Hemoglobin greater than or equal to 10 gm/dL (100 gm/L). Patients may have received transfusions and/or erythropoietin to attain this value. However, they must have been stable without treatment for at least one week in order to be eligible. * Serum creatinine less than 1.5 times the upper limit of normal. * Total bilirubin less than 1.5 times the upper limit of normal. * SGPT less than or equal to 5.0 times upper limit of normal. - Able to provide written informed consent. - Negative pregnancy test (female patients of childbearing potential only), after signing informed consent and prior to registration. Exclusion criteria: - Patients who are poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection. - Uncontrolled heart disease (symptomatic ischemic heart disease or congestive heart failure, or any heart condition that cannot be controlled with regular ongoing medication). - Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient’s understanding of the informed consent. - Prior therapy with interferon. - Chemotherapy, radiation therapy, biologic therapy, or surgery within four weeks prior to administration of SCH 54031. - Lack of resolution of all toxic manifestations of prior chemotherapy, biologic or radiation therapy. - Known HIV positivity or AIDS-related illness. - Pregnancy or lactation. - Men or women of childbearing potential who are not using an effective method of contraception. - Preexisting thyroid abnormalities for which thyroid function cannot be maintained in the normal range by medication - CNS trauma or active seizure disorders requiring medication. - Poorly controlled diabetes mellitus. - Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease), documented pulmonary hypertension. - Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis). - Hemoglobinaopathies (e.g., thalassemia) or any other cause of hemolytic anemia. - Evidence of decompensated liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.
Total Enrollment: 72
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Katharine Gillaspy 713-745-6775
Additional Information:
Study ID Numbers: ID01-450;
Study Start Date: February 2004
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078416
Other Head And Neck Cancer Studies:
1. Chemotherapy With or Without Gene Therapy in Treating Patients With Unresectable Recurrent Head and Neck Cancer
2. Chemotherapy in Treating Patients With Solid Tumors
3. Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
4. Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
5. Radiation Therapy in Treating Patients With Head and Neck Cancer
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Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
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