RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have advanced salivary gland cancer.

Condition	Treatment or Intervention	Phase
salivary gland malignant mixed cell type tumor salivary gland poorly differentiated carcinoma stage III salivary gland cancer stage IV salivary gland cancer recurrent salivary gland cancer salivary gland acinic cell tumor salivary gland adenoid cystic carcinoma low-grade salivary gland mucoepidermoid carcinoma high-grade salivary gland mucoepidermoid carcinoma salivary gland squamous cell carcinoma salivary gland adenocarcinoma	Drug: trastuzumab	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate to trastuzumab in patients with advanced or metastatic salivary gland cancer. II. Determine the time to progression in these patients after this regimen. III. Determine the toxicity of trastuzumab in these patients.

PROTOCOL OUTLINE: Patients are stratified according to histology: intercalated duct (adenoid cystic carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, adenocarcinoma) vs excretory duct (squamous cell carcinoma, mucoepidermoid carcinoma). Patients receive trastuzumab IV over 30-90 minutes weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven locally unresectable or metastatic malignancy arising from salivary tissue; Adenoid cystic carcinoma; Polymorphous low grade adenocarcinoma Mucoepidermoid carcinoma; Undifferentiated carcinoma; Acinic cell carcinoma; Squamous cell carcinoma; Malignant mixed tumor; Adenocarcinoma
• Unidimensionally measurable disease
• Overexpression of Her2/neu protein

--Prior/Concurrent Therapy--

• Biologic therapy: At least 4 weeks since prior immunologic therapy; No other concurrent immunologic therapy
• Chemotherapy: No more than 2 prior regimens of cytotoxic chemotherapy for salivary gland cancer; No prior doxorubicin of more than 360 mg/m2; No concurrent chemotherapy
• Endocrine therapy: At least 4 weeks since prior hormonal therapy; No concurrent hormonal therapy
• Radiotherapy: No concurrent radiotherapy
• Surgery: Not specified
• Other: At least 4 weeks since prior homeopathic, natural, or alternative medicine therapy; No concurrent homeopathic, natural, or alternative medicine therapy

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0 or 1
• Life expectancy: Greater than 3 months
• Hematopoietic: Absolute neutrophil count greater than 1999/mm3; Platelet count greater than 99,999/mm3; Hemoglobin greater than 8.5 g/dL OR Hematocrit greater than 25%
• Hepatic: Bilirubin less than 2 times upper limit of normal (ULN); SGOT less than 2 times ULN; (less than 5 times ULN if liver involvement) Alkaline phosphatase less than 5 times ULN (no restriction if bone or liver involvement)
• Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance at least 50% lower limit of normal
• Cardiovascular: Must have normal cardiac contractility by MUGA if received prior anthracyclines (doxorubicin, daunorubicin, epirubicin); No congestive heart failure
• Pulmonary: No chronic obstructive pulmonary disease
• Other: No prior other malignancy with past 3 years except curatively treated nonmelanoma skin cancer or cervical cancer; No significant active illness; No uncontrolled diabetes; No AIDS; Not pregnant or nursing; Fertile patients must use effective contraception

Connecticut
      Yale-New Haven Hospital, New Haven,  Connecticut,  06504,  United States
Florida
      Hematology/Oncology Associates, Port Saint Lucie,  Florida,  34952,  United States
Massachusetts
      Cape Cod Health Care, Hyannis,  Massachusetts,  02601,  United States
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
      Nantucket Cottage Hospital, Nantucket,  Massachusetts,  02554,  United States
Missouri
      Washington University Barnard Cancer Center, Saint Louis,  Missouri,  63110,  United States
New York
      Lourdes Regional Cancer Center, Binghamton,  New York,  13905,  United States
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Marshall R. Posner,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000067405; DFCI-98286; NCI-G99-1628
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004163
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08