Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Recurrence

Carcinoma

Salivary Gland Neoplasms

Carcinoma, Adenoid Cystic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Adenocarcinoma

Adenoid Cystic Carcinoma

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Stuart Wong

This phase II trial is studying how well dasatinib works in treating patients with malignant salivary gland tumors that have come back after treatment or have spread to other parts of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. Determine the objective response rate (complete response plus partial response) of dasatinib in adenoid cystic carcinoma (ACC).

II. Determine the progression-free survival of dasatinib in ACC.

SECONDARY OBJECTIVES:

I. Determine the duration of response. II. Determine the stable disease rate and duration of stable disease. III. Determine progression-free survival. IV. Determine the median survival. V. Determine the overall survival. VI. Determine the safety and tolerability.

TERTIARY OBJECTIVES:

I. To examine biomarkers that relate to SRC proto-oncogene, non-receptor tyrosine kinase (Src) signal transduction and to correlate these biomarkers with clinical response to dasatinib in ACC and non-ACC malignant salivary gland tumors (MSGT).

II. Determine if activating mutations in platelet-derived growth factor alpha polypeptide (PDGFA) and KIT are associated with response in ACC.

OUTLINE:

Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 8 weeks.

Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors

Phase II Trial of Dasatinib (BMS 354825) for Recurrent or Metastatic c-KIT Expressing Adenoid Cystic Carcinoma and Non-adenoid Cystic Malignant Salivary Tumors

Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.

Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.

Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.

Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.

National Cancer Institute (NCI)

All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.

Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Non Adenoid Cystic Carcinoma

Total

Age, Continuous

Sex: Female, Male

Dr. Stuart Wong

Complete response

Partial response

Stable disease

Progressive disease

Other

There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.

Response Rate

Progression-free Survival

Overall Survival

Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.

Changes in Laboratory Correlates

Overall Study

Spots Global Cancer Trial Database for malignant salivary gland neoplasm