Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 1999|
|Trial identifier||NCT00004163, CDR0000067405, DFCI-98286, NCI-G99-1628|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|New Haven, CT||Yale-New Haven Hospital||no longer recruiting|
|Port Saint Lucie, FL||Hematology/Oncology Associates||no longer recruiting|
|Boston, MA||Dana-Farber Cancer Institute||no longer recruiting|
|Boston, MA||Massachusetts General Hospital Cancer Center||no longer recruiting|
|Hyannis, MA||Cape Cod Health Care||no longer recruiting|
|Nantucket, MA||Nantucket Cottage Hospital||no longer recruiting|
|Saint Louis, MO||Washington University Barnard Cancer Center||no longer recruiting|
|Binghamton, NY||Lourdes Regional Cancer Center||no longer recruiting|
|Philadelphia, PA||Fox Chase Cancer Center||no longer recruiting|
|Houston, TX||University of Texas - MD Anderson Cancer Center||no longer recruiting|
Male or female participants at least 18 years old.
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 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 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
|Official title||Herceptin In Patients With Advanced or Metastatic Salivary Gland Carcinomas|
|Description||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. 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.|
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