Adrenal Gland Disorders |
Adrenal Disease; Disorder |
Clinical Trial: Trastuzumab in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) August 2005
Purpose
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with metastatic or recurrent salivary gland cancer.
| Condition | Intervention | Phase |
|---|---|---|
| recurrent salivary gland cancer high-grade salivary gland mucoepidermoid carcinoma salivary gland acinic cell tumor stage IV salivary gland cancer salivary gland poorly differentiated carcinoma salivary gland adenocarcinoma | Drug: trastuzumab Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: monoclonal antibody therapy | Phase II |
MedlinePlus related topics: Oral Cancer; Salivary Gland Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Trastuzumab (Herceptin ®) in Patients With Metastatic or Recurrent High-Grade Salivary Gland Carcinoma
OBJECTIVES:
- Determine the response (confirmed and unconfirmed, complete and partial) in patients with metastatic or recurrent high-grade salivary gland carcinoma treated with trastuzumab (Herceptin ®).
- Determine 1-year progression-free and overall survival of patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
- Correlate, preliminarily, the indicators of C-erb B2 oncoprotein expression, C-erb B2 oncogene amplification, and epidermal growth factor receptor expression with response and progression-free and overall survival of patients treated with this drug.
OUTLINE: Patients receive trastuzumab (Herceptin ®) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 3 months for 1 year and every 6 months until 3 years from study entry.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 10-18 months.
Eligibility
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed high-grade (poorly differentiated or undifferentiated) salivary gland carcinoma, including any of the following histological subtypes:
- Adenocarcinoma
- Acinic cell carcinoma
- Mucoepidermoid carcinoma
- Salivary duct carcinoma
- Undifferentiated carcinoma
- Metastatic or recurrent disease
- Not amenable to salvage surgical resection or radiotherapy
- Tumors must demonstrate HER2/neu gene amplification by fluorescence in situ hybridization (FISH) OR overexpression of HER2/neu protein ( 2+ or 3+) by immunohistochemistry
- Measurable disease
- No adenoid cystic carcinoma
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 2,000/mm^3
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
Hepatic
- Bilirubin ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
Renal
- Creatinine < 2.5 times ULN
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- No history of allergic reaction to compounds of similar chemical or biological composition to trastuzumab
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent filgrastim (G-CSF)
Chemotherapy
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy except steroids for emesis, adrenal failure, or septic shock or hormones for non-disease-related conditions (e.g., insulin for diabetes)
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery
- At least 4 weeks since prior surgery and recovered
Other
- No other concurrent investigational agents
Location and Contact Information
Madeleine A. Kane, MD, PhD, Study Chair, University of Colorado Cancer Center
Richard H. Wheeler, MD, University of Utah
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: August 16, 2005
Record first received: August 2, 2005
ClinicalTrials.gov Identifier: NCT00126607
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- AACE Physician Finder (American Association of Clinical Endocrinologists)
- ACTH (Adrenocorticotropic Hormone) Test (American Association for Clinical Chemistry)

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