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Home > "T" Clinical Trials Conditions > Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer  Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
For Condition: salivary gland poorly differentiated carcinoma,salivary gland acinic cell tumor,salivary gland adenoid cystic carcinoma,salivary gland squamous cell carcinoma,low-grade salivary gland mucoepidermoid carcinoma,high-grade salivary gland mucoepidermoid carcinoma,salivary gland malignant mixed cell type tumor,stage 3 salivary gland cancer,stage 4 salivary gland cancer,salivary gland adenocarcinoma,recurrent salivary gland cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Dana-Farber/Harvard Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarshallPosner, Study Chair, Dana-Farber/Harvard Cancer Center
Lourdes Regional Cancer Center
Binghamton, New York, 13905
United States
Yale-New Haven Hospital
New Haven, Connecticut, 06504
United States
Cape Cod Health Care
Hyannis, Massachusetts, 02601
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Washington University Barnard Cancer Center
St. Louis, Missouri, 63110
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, 34952
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Nantucket Cottage Hospital
Nantucket, Massachusetts, 02554
United States
Additional Information:
Study ID Numbers: CDR0000067405; DFCI-98286,NCI-G99-1628
Study Start Date: January 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004163
Other Salivary Gland Squamous Cell Carcinoma Studies:
1. Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
Related Studies:
Other salivary gland squamous cell carcinoma Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
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