Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin. It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more effective than observation in preventing recurrence of head and neck cancer after surgery and/or radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery and/or radiation therapy for stage III or stage IV head and neck cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: alpha-Tocopherol; Interferon-alpha; Interferons; Isotretinoin; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck

• Primary site must be within the oral cavity, oropharynx, larynx, or hypopharynx

• Stage III or IV primary lesion at diagnosis

• No distant metastatic disease at diagnosis

• No multiple primary lesions

• Currently disease-free after treatment with 1 of the following:

• Complete tumor resection

• Radiotherapy or chemoradiotherapy alone*

• Resection followed by radiotherapy/chemoradiotherapy*

• No more than 4-16 weeks since prior surgery and/or radiotherapy/chemoradiotherapy NOTE: *Radiotherapy must have been 70-72 Gy in 1.8-2.0 Gy fractions to the primary tumor and clinically positive neck nodes and 44-50 Gy in 1.8-2.0 Gy fractions to clinically negative nodes, including the lower neck

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• AST and ALT no greater than 2 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2 times ULN

Renal

• Creatinine no greater than 1.2 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for 1 month prior to, during, and for 1 month after study therapy

• Electrolytes normal

• Fasting serum triglyceride level no greater than 2 times ULN (anti-triglyceride medication allowed)

• No other malignancy within the past 2 years except localized basal cell or squamous cell skin cancer

• No other concurrent medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy and recovered

• Prior neoadjuvant chemotherapy allowed

• Prior chemotherapy administered concurrently with radiotherapy allowed

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• Recovered from prior radiotherapy

Surgery

• See Disease Characteristics

• Recovered from prior surgery

Other

• No history of megadose vitamin A (more than 25,000 I.U.)

• No other clinical trial enrollment that would preclude adjuvant systemic therapy

• No concurrent vitamin supplements containing vitamin A