Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery

Completed · Phase 1

Conditions studied: Adult Acute Lymphoblastic Leukemia in Remission, Adult B Acute Lymphoblastic Leukemia, Adult Hepatocellular Carcinoma, Adult Nasal Type Extranodal NK/T-Cell Lymphoma, Adult Solid Neoplasm, Adult T Acute Lymphoblastic Leukemia, Advanced Adult Hepatocellular Carcinoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-Cell Lymphoma, Chronic Lymphocytic Leukemia, Cutaneous B-Cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Hepatosplenic T-Cell Lymphoma, Intraocular Lymphoma, Localized Non-Resectable Adult Liver Carcinoma, Localized Resectable Adult Liver Carcinoma, Lymphomatous Involvement of Non-Cutaneous Extranodal Site, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Nodal Marginal Zone Lymphoma, Progressive Hairy Cell Leukemia Initial Treatment, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Lymphoma, Recurrent Adult Liver Carcinoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-Cell Leukemia/Lymphoma, Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides and Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestinal Lymphoma, Splenic Marginal Zone Lymphoma, Stage II Small Lymphocytic Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-Cell Leukemia/Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IIIA Mycosis Fungoides and Sezary Syndrome, Stage IIIB Mycosis Fungoides and Sezary Syndrome, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-Cell Leukemia/Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Stage IVA Mycosis Fungoides and Sezary Syndrome, Stage IVB Mycosis Fungoides and Sezary Syndrome, T-Cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Hairy Cell Leukemia, Waldenstrom Macroglobulinemia

In brief

This phase I trial studies the side effects and best dose of dasatinib in treating patients with solid tumors or lymphomas that are metastatic or cannot be removed by surgery. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT00608361
Run by: National Cancer Institute (NCI)
People needed: 80
Starts: 2008-10-01
Expected to finish: 2014-08-01
Last updated by the study team: 2015-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed solid tumor or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with a liver mass, elevated alpha-fetoprotein level (>= 500 ng/mL) and positive serology for viral hepatitis, consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis; all solid and lymphoma tumor types are eligible
Patients must have measurable or non-measurable disease; x-rays and/or scans for disease assessment must have been completed within 28 days (for measurable disease) or 42 days (for non-measurable disease) prior to registration; all disease must be assessed and documented on the web-based Baseline Tumor Assessment Form
Patients with brain metastases who require corticosteroids must be on stable or decreasing dose of corticosteroids; patients with known brain metastases must have had brain irradiation (whole brain or gamma knife); patients with untreated (non-irradiated) brain metastases are not eligible; patients on enzyme-inducing anticonvulsant medications (e.g. phenobarbital, phenytoin or carbamazepine) are not eligible
Patients must not be taking H2-receptor antagonists such as cimetidine, ranitidine, and famotidine, or any proton pump inhibitors, such as omeprazole, lansoprazole, esomeprazole, and pantoprazole; patients must stop these medications within 7 days prior to starting treatment
Patients must not have had anticancer therapy including chemotherapy, radiotherapy, immunotherapy, or investigational agent within 4 weeks prior to registration, except for targeted agents with half-life known to be < 24 hours; patients must not have had targeted agents with half-life < 24 hours within 2 weeks prior to registration; patients also must have recovered from serious adverse events due to agents administered within these acceptable time frames
Patients must not be planning to receive concurrent radiation, other chemotherapy, immune therapy or any other investigational agents for malignancy while receiving protocol treatment; hormonal treatment for prostate carcinoma may be continued and bisphosphonate treatment for bone disease is permitted
Patient must not have received prior therapy with dasatinib (BMS-354825)
Patients for whom there is a strong suspicion of being allergic to dasatinib because of a history of allergic reactions to similar compounds are not eligible
Patients must not have had major surgical procedures within the last 4 weeks prior to the first planned dose of study drug
Patients must not be taking therapeutic doses of anticoagulants; low dose warfarin for port prophylaxis is permitted
Zubrod performance status of 0-2
Patients may not have any clinically significant cardiovascular disease including the following:
Myocardial infarction or ventricular tachyarrhythmia within 6 months
Prolonged corrected QT interval (QTc) >= 480 msec (Fridericia correction)
Ejection fraction less than institutional normal
Major conduction abnormality (unless a cardiac pacemaker is present)
Patients with any cardiopulmonary symptoms of unknown cause (e.g. shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation; the patient may be referred to a cardiologist at the discretion of the principal investigator; patients with underlying cardiopulmonary dysfunction should be excluded from the study
Absolute neutrophil count >= 1.5 x 10\^9/L
Platelets >= 100 x 10\^9/L
Magnesium >= lower limit of normal (LLN)
Potassium >= LLN
Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min/1.73 m\^2; if less than the normal range, supplementation should be initiated in the manner deemed appropriate by the treating physician
Patients with abnormal liver function are eligible and will be grouped according to the criteria; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; for patient registration, liver function tests (total bilirubin, aspartate aminotransferase [AST]/alanine aminotransferase [ALT], prothrombin time [PT]/international normalized ratio [INR] and partial thromboplastin time [PTT], and alkaline phosphatase) must be performed within 14 days prior to registration; for patient stratification, liver function tests must be performed within 72 hours of anticipated starting time of protocol treatment; patients must be stratified and treated based on the liver function tests performed within 72 hours prior to treatment; the South West Oncology Group (SWOG) Data Operations Center must be notified in writing in cases where the patient's cycle 1 pre-treatment liver function tests result in stratification to a dysfunction group different from how the patient was classified at registration
Patients with biliary obstruction for which a shunt has been placed are eligible, provided the liver function tests have stabilized (two measurements at least two days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function); there must be no evidence of biliary sepsis and at least 2 weeks must have elapsed after the placement of a biliary shunt
Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; since interaction with dasatinib and oral contraceptives is possible, a barrier method should be used and oral contraceptives are not permitted; a negative pregnancy test is required within 72 hours prior to starting therapy for women of reproductive potential; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

Where it is running

City of Hope Comprehensive Cancer Center — Duarte, California, United States
Los Angeles County-USC Medical Center — Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
Hays Medical Center — Hays, Kansas, United States
Hutchinson Regional Medical Center — Hutchinson, Kansas, United States
University of Kansas Cancer Center — Kansas City, Kansas, United States
Olathe Cancer Center — Olathe, Kansas, United States
Via Christi Hospital-Pittsburg — Pittsburg, Kansas, United States
Salina Regional Health Center — Salina, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka — Topeka, Kansas, United States
Henry Ford Hospital — Detroit, Michigan, United States
Truman Medical Center — Kansas City, Missouri, United States
Audie L Murphy Veterans Affairs Hospital — San Antonio, Texas, United States
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio — San Antonio, Texas, United States
University Hospital — San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
Scott and White Memorial Hospital — Temple, Texas, United States
Swedish Medical Center-Edmonds — Edmonds, Washington, United States
Swedish Cancer Institute-Issaquah — Issaquah, Washington, United States
Swedish Medical Center-Ballard Campus — Seattle, Washington, United States
Swedish Medical Center-First Hill — Seattle, Washington, United States
University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.