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A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas Clinical research trials and A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas. A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas clinical trial. Test subjects typically receive the most effective healthcare possible for their A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas  A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas
A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas
For Condition: Cancer,Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The purpose of this study is to learn about a new investigational drug called MS-275. It has been shown to block the growth of cancer cells in animals. This study's goal is to understand how the drug works in humans, what side effects are common, and what dose is safe. This is the first time this drug has been given to humans. Patients with solid tumors or non-Hodgkin's lymphoma resistant to treatment and those for whom there is no curative treatment will be eligible. Potential participants will undergo a series of tests to determine eligibility. Bone scans and CT scans will be done to determine the extent of the cancer; blood and urine studies will be done to determine whether this drug can be safely administered. Chest X-ray and EKG will also be done. Eligible patients will be admitted to the NIH hospital for two days and will receive MS-275 in tablet form each day. After leaving NIH, patients will take the same dose with a meal at the same time each day for 28 days. For the next 14 days, the drug will be stopped. Then it will be taken for another 28 days. Patients must return to the clinic at the end of weeks 2 and 4 and at the beginning of week 7 and every 6 weeks thereafter. Blood samples will collected on day 1, day 2, day 14, and day 28 of each cycle. In addition, some of the studies will be repeated every 3 months. A needle biopsy may be requested on day 1 and day 28 of treatment. The therapy may be continued beyond 6 months if the patient's cancer is not progressing and side effects are not severe. If side effects are severe, the dose may be lowered. When this drug was given to animals, side effects included decreased food intake, vomiting, diarrhea, weight loss, and a temporary decrease in white cells or platelets in the blood.
Details: Histone deacetylases (HDAC) are critically important in the regulation of gene expression and in the field of target-specific anticancer drug development. Several HDAC inhibitors have been shown to have a wide range of effects including gene activation, cellular differentiation, cell growth arrest and apoptosis. The HDAC inhibitor MS-275, a benzamide derivative, has demonstrated potent and unique cytotoxicity and anticancer activity in vitro in human tumor cell lines and, more importantly, in vivo in human tumor xenografts. The purpose of this MS-275 Phase I trial is to explore a potential novel chemotherapeutic agent for cancers which are insensitive to traditional antitumor agents. Patients with solid tumors and non-Hodgkin's lymphomas refractory to standard therapy, or for those for whom there is no known standard therapy potentially curative or capable of extending life expectancy, will be evaluated for study eligibility without consideration of race, ethnic origin, sex or sexual orientation. Due to absence of experience in using MS-275 in humans, children, pregnant women and HIV-infected individuals are excluded from this study. This study will initially evaluate the toxicity and pharmacokinetics of MS-275 when given as a single dose initially on an every two week schedule (referred to in the text as the q.o. wk schedule). The focus will then shift to evaluating the toxicity and pharmacokinetics of MS-275 administered on a once weekly schedule in two formulations: one will be in an uncoated version administered with prior meal, and a coated version to be administered in the fasted state. Also, MS-275 induced changes in HDAC activity and gene expression in relation to its anticancer activity will be analyzed in this trial.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 1. Patients must have a pathologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or would likely not be effective. 2. ECOG performance status of less than or equal to 2 (Karnofsky greater than or equal to 50 percent), with no recent (within 2 month) weight loss of greater than 10 percent of average body weight. 3. Life expectancy is greater than 3 months. 4. Age greater than or equal to 18 years. 5. Patients must have normal organ and marrow functions as defined below: - Leukocytes greater than or equal to 3000/microL. - Absolute neutrophil count greater than or equal to 1500/microL. - Platelets greater than or equal to 100,000/microL. - Creatinine within normal limits or measured creatinine clearance equal to or greater than 60 ml/min/1.73m(2). - Total bilirubin less than or equal to 1.5 upper limit of normal. - AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x upper limit of normal. 6. Adequate oral intake and serum albumin greater than or equal to 75% of lower limit normal. 7. Willingness and ability to return to the NCI for follow-up. 8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 9. Ability to understand and the willingness to sign a written informed consent document. 10. Willingness and ability to self-administer and document the doses of MS 275. EXCLUSION CRITERIA: 1. Patients who have had anticancer therapy (chemotherapy, radiotherapy, vaccines and hormone therapy with the exception of GnRH agonists) within the last 4 weeks (6 weeks for nitrosoureas or mitomycin C, 8 weeks for UCN-01); or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2. Patients may not be receiving any other investigational agents. 3. Patients with known brain metastases should be excluded from this clinical trial. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to MS-275. 5. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, seizure disorder or psychiatric illness/social situations that would limit compliance with study requirements. 6. Pregnant women are excluded from this study. Breastfeeding should be discontinued if the mother is treated with MS-275. 7. HIV-positive patients are excluded from this study. 8. Men and women of reproductive potential without adequate contraception. 9. Recent (within two months of therapy inception) acute or chronic gastrointestinal conditions (e.g., peptic ulcer or colitis) that might predispose for drug intolerability or poor drug absorption. 10. Major surgery within the past 21 days. 11. Intercurrent radiation, chemotherapy, immunotherapy or hormonal therapy (except for GnRH agonists). 12. Patients meeting the criteria for suspected Gilbert's Syndrome.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 010124; 01-C-0124
Study Start Date: March 12, 2001
Record last reviewed: February 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012571
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2. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
3. In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients
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A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas
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