ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: A specially modified virus called ONYX-015 may be able to kill tumor cells while leaving normal cells undamaged. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ONYX-015 with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of ONYX-015 combined with cisplatin and fluorouracil in treating patients who have advanced head and neck cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: Dana-Farber Cancer Institute
• Treatments: Cisplatin; Dl1520; Fluorouracil; ONYX015

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) that is incurable by standard therapy

• Measurable or evaluable disease

• Multiple SCCHN primaries allowed

• Metastases allowed if tumor to be treated is confined to head and neck region

--Prior/Concurrent Therapy--

• Biologic therapy: Recovered from prior biologic therapy

• Chemotherapy: At least 3 weeks since prior chemotherapy and recovered

• Endocrine therapy: Recovered from prior endocrine therapy

• Radiotherapy: At least 12 weeks since prior radiotherapy and recovered

• Surgery: Recovered from prior surgery

• Other: Recovered from any prior diagnostic or theraputic procedures

--Patient Characteristics--

• Age: 18 to physiologic 79

• Performance status: ECOG 0-2

• Life expectancy: Over 3 months

• Hematopoietic: WBC greater than 3,000/mm3 OR Absolute neutrophil count greater than 2,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 10 g/dL (transfusions allowed if not used solely to meet eligibility criteria)

• Hepatic: SGOT less than 2.5 times upper limit of normal (ULN); Alkaline phosphatase less than 3 times ULN; Bilirubin no greater than 1.5 times ULN

• Renal: Creatinine less than 1.6 mg/dL OR Creatinine clearance greater than 50 mL/min

• Cardiovascular: No active cardiovascular disease that would limit physical activity (i.e., ability to walk 50 feet without stopping)

• Pulmonary: No active pulmonary disease that would limit physical activity (i.e., ability to walk 50 feet without stopping)

• Other: No other prior or concurrent malignancy within the past 3 years except limited basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; Adequate and nutritionally balanced enteral intake of at least 1,800 kcal/day (enteral feeding tube dependent allowed); No intravenous alimentation as primary source of calories; No other serious illness or medical condition that would preclude study (i.e., active systemic lupus erythematosus, Crohn's disease or AIDS); No prior immunodeficiency (i.e., HIV infection, organ transplant, or chronic steroid use); Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception