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Perifosine to Treat Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Perifosine to Treat Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Perifosine to Treat Prostate Cancer Clinical research trials and Perifosine to Treat Prostate Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Perifosine to Treat Prostate Cancer. Perifosine to Treat Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Perifosine to Treat Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Perifosine to Treat Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Perifosine to Treat Prostate Cancer  Perifosine to Treat Prostate Cancer
Perifosine to Treat Prostate Cancer
For Condition: Prostate Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the safety and effectiveness of perifosine in treating metastatic androgen-independent prostate cancer (advanced prostate cancer that does not respond to hormone therapy). Perifosine is one of a new class of anticancer drugs called alkylphospholipids (ALKS) that show broad anticancer activity in preclinical studies. Also, in preliminary clinical studies, perifosine stabilized prostate cancer in some patients. Patients 18 years of age and older with advanced prostate cancer that does not respond to hormone therapy may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, tumor biopsy if the tumor is accessible, and x-ray, CT & Bone scans to evaluate the location and extent of disease. Participants will take perifosine in 28-day cycles. Each cycle consists of taking the drug by mouth for 21 days, stopping for 7 days, and then repeating the cycle. Depending on the response to treatment, therapy could last more than 6 months. Patients will keep a daily record of symptoms and drug side effects. Patients whose tumor does not grow during the first three cycles and who do not experience unacceptable treatment side effects will continue the 4-week cycles. Patients who develop unacceptable side effects will stop treatments. In addition to drug therapy, participants will undergo the following procedures: - Physical examinations - Blood tests every 28 days to measure drug levels, determine the effect of drug on tumor cells, and look for changes in chemical signals produced in response to the drug. - Blood tests at home on day 15 of the first cycle of drug to make sure red & white blood cell counts and electrolytes as well as kidney & liver functions are not reaching harmful levels. - Serial blood draws during the first month of treatment to measure blood levels of perifosine - Blood will be taken before the first drug dose and 8 and 48 hours after the dose. This first dose is a, loading dose, which is larger than the normal study dose. Patients will be admitted to the hospital for 4 days for the serial blood draws. - Imaging studies (e.g., bone scan or CT scan) every 2 months for the first 4 months and every 3 months after that to determine the tumor response to therapy. - Oral bushings of cells lining the inner surface of the cheeks, along with saliva samples taken before the first drug dose and on days 3 and 28 of treatment to study the effects of perifosine on cells. - Tumor biopsies (in patients with accessible tumors) taken before treatment and 4 weeks after treatment begins. A biopsy is the surgical removal of a small piece of tumor tissue for microscopic examination. - Leukapheresis before beginning treatment and days 3 and 28 of treatment to evaluate the effect of perifosine on blood cells. For this procedure a needle is placed in a vein and whole blood is collected. The blood flows through a cell separator machine where the mononuclear cells (a type of white blood cell) are removed for testing, and the rest of the blood is returned to the patient. - Testosterone suppression to prevent tumor growth. Prostate cancer cells in the body may continue to grow if they are exposed to the male hormone testosterone. Testosterone is suppressed either surgically by removing the testicles, or medically with an injection of leuprolide or goserelin (leuteinizing hormone-release hormone, or LHRH agonist). LHRH agonists reduce testosterone levels.
Details: Perifosine represents a new class of anticancer drug, alkylphospholipids (ALKS), and exhibits broad antineoplastic activity in preclinical studies. In phase I trials it was well tolerated with gastrointestinal symptoms and arthralgias as major dose limiting toxicities. The primary objective of this study is to determine whether perifosine, when used to treat metastatic androgen independent prostate cancer (AIPC), is associated with 50% or greater patients progression free at 4 months by PSA and clinical criteria. Ancillary correlative studies on serially obtained tumor tissue biopsies, oral keratinocytes, and peripheral blood mononuclear cells (PBMCs) will also be conducted. These laboratory correlates will include the determination of cell cycle parameters including D-type cyclins and p21WAF1 expression, as well as phosphorylation of Rb. Circulating tumor cell DNA P53 mutation and quantitative circulating prostate tumor cell analysis will be performed as well. In addition, proinflammatory cytokines will be assessed. Pharmacokinetic analysis will be done in all patients to compare to the results from our phase I clinical trial at the Clinical Center and to correlate with the molecular endpoints as well as clinical activity observed. In addition, gene expression array and proteomics will be performed from tumor tissues by Laser Capture Microdissection. This clinical evaluation of perifosine will provide new information on the clinical antitumor effects and surrogate molecular endpoints, as well as the potential in vivo mechanisms of action for this novel agent.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA Patients must have histopathological documentation of prostate adenocarcinoma confirmed in the Laboratory of Pathology, NCI at the National Institutes of Health or the National Naval Medical Center prior to starting this study. Patients whose pathology specimens are no longer available may be enrolled in the trial, if the patient has a clinical course consistent with prostate cancer and pathologic documentation of the diagnosis. Patients must have metastatic progressive androgen-independent prostate cancer (progressive prostate cancer while continuing to receive hormonal ablation, such as that of an LHRH agonist) documented prior to entry. Patients can be either chemotherapy-naive or previous treated with one chemotherapy regimen. Patients must be at least 4 weeks off of flutamide or chemotherapy and 6 weeks off of bicalutamide and nilutamide. Progression must be documented by at least one of the following parameters: Two consecutively rising PSA levels, separated by at least one week, with at least one measurement that is 50% above the nadir reached after the last therapeutic maneuver (as long as the last measurement is 5 ng/ml or greater), and/or At least one new metastatic lesion on Tc-99 bone scintigraphy, and/or Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging, palpation). Development of new area of malignant disease (measurable or non-measurable) At least a 20% increase in the sum of the (longest diameter) LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Patients who have not undergone surgical castration must have a serum testosterone under 50 ng/ml and continue on their LHRH agonist. Patients must be 18 years of age or older. Patients must have a life expectancy of more than 3 months. Patients must have a performance status of 0 to 2 according to the ECOG criteria . Patients must have normal organ and marrow function as defined below: - leukocytes 3,000/mL or greater - absolute neutrophil count of 1,500/mL or greater - platelets 100,000/mL or greater - total bilirubin less than 1.0 mg/dl or upper limit of normal - AST(SGOT)/ALT(SGPT) less than or equal to 2.5 times institutional upper limit of Normal. - creatinine less than or equal to 1.5 mg/dl (if greater than 1.5 mg/dL, measured creatinine clearance must be at least 60 mL/min). Patients must have recovered from any acute toxicity related to prior therapy, including surgery or radiotherapy. Patients must be willing to travel from their home to the NIH for follow-up visits. Patients must be greater than or equal to 6 weeks from nitrosureas, mitomycin C, or bone seeking radioisotopes prior the entry. Patients treated with suramin and or UCN-01 should be greater than 3 months from last day of treatment. Patients must be able to ingest oral medications. The effects of perifosine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (abstinence or barrier method of birth control) prior to study entry and for the duration of study participation. Patients must have ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA Patients may not be receiving any other investigational agents. Patients with known brain metastases will be ineligible for this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or Edelfosine). Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine. Patients who have active malignancies within the past two years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) will be excluded from the study. Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure. Since irreversible retinal degenerations were observed in preclinical toxicity studies in rats, patients with pre-existing retinal disease, or known pathologic baseline electrooculogram are not eligible. However, because ocular toxicities were not observed in our Phase I trial of this drug, no additional monitoring will be included.
Total Enrollment: 46
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 030157; 03-C-0157
Study Start Date: April 7, 2003
Record last reviewed: March 17, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058708
Other Prostate Cancer Studies:
1. Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
2. A Safety and Feasibility Study of Active Immunotherapy in Patients with Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed with Antigen Encoded in Amplified Autologous Tumor RNA
3. Study of CEP-701 in Treatment of Prostate Cancer
4. GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors
5. Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated with One Cytotoxic Chemotherapy Regimen
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Perifosine to Treat Prostate Cancer
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