|
Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas 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 Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas Clinical research trials and Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas 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 Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas. Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas 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 Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas clinical trial. Test subjects typically receive the most effective healthcare possible for their Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas 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.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas  Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas
Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas
For Condition: Glioma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine the highest dose of the experimental drug CC-5013 that can safely be given to patients with gliomas (a type of brain tumor). Gliomas are nourished by blood delivered through blood vessels whose formation is stimulated by substances produced by the tumor itself. Stopping the growth of new vessels can slow or prevent tumor growth. CC-5013 is closely related chemically to thalidomide, a drug that can block development of new blood vessel formation. In two studies of patients with brain tumors, thalidomide stopped the growth of gliomas in about one half the patients. However, in most patients the effect only lasted for several months. CC-5013 is much more potent than thalidomide, and may, therefore, be more effective in controlling tumor growth. This study will examine the drug's safety and optimum dosage level as a first step in evaluating its usefulness in treating gliomas. Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing and does not respond to radiation therapy may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests (including a pregnancy test for women of childbearing potential), and magnetic resonance imaging (MRI) or computed tomography (CT) of the head. Participants will take CC-5013 capsules once a day for 3 weeks, followed by 1 week off medication. To find the highest tolerable dose, the first group of three patients in the study will start at a low dose, and the dose will be increased gradually in succeeding groups of three patients until side effects become unacceptable. All subsequent patients will then receive the next lower dose, which is the maximum tolerated, or optimum, dose. Patients will continue treatment for up to 12 cycles (about 1 year) as long as the drug is tolerated without serious side effects and the tumor is not growing. After that, the decision to continue or stop therapy will be reviewed. Patients whose tumor grows significantly or who develop unacceptable side effects will be taken of the study. While on the study, patients will undergo various tests and procedures as follows: - Physical and neurologic examinations every 2 weeks for the first 4-week cycle and every 4 weeks after that - MRI or CT brain scan every 4 weeks. MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure. CT produces images of the brain in small sections. It can be done from different angles to show a three dimensional picture. - Routine blood tests every 2 weeks for the first 2 cycles and then every 4 weeks - Blood drawing immediately before and then 1/2, 1, 2, 4, 6, 8, 24, and 48 hours after the first drug dose on days 1 and 21 to measure CC-5013 blood levels. - Blood tests every 4 weeks to detect substances that stimulate new blood vessel growth or to determine blood levels of CC-5013 Patients may also be asked to undergo magnetic resonance with spectroscopy (MRS) or PET scanning to help distinguish live tumor from dying tumor. The experience of having MRS is identical to that of the standard MRI and will be done at the same time as the MRI. PET shows cellular activity in the brain. For this test, a sugar solution with a radioactive particle attached is injected through a vein. The radioactive substance allows the fluid to be seen with a special gamma camera. The sugar is fuel for cells and is taken up by the most active cells. Since cancer cells are very active, tracing the sugar uptake allows detection of tumor.
Details: Malignant gliomas are an important cause of cancer-related morbidity and mortality in the United States. Given the relatively poor activity of most cytotoxic agents in the treatment of malignant gliomas, new agents with novel mechanisms of action are needed. Inhibition of new vascular formation offers a potentially promising new approach for treating these relatively refractory tumors based on the dependence of glioma growth on angiogenesis. In this respect, thalidomide appears to have biologic activity in malignant gliomas, however that activity may be too small to be clinically useful as a single agent. CC-5013 is a thalidomide analog with nearly 1000 times the biologic activity in vitro. Like the thalidomide parent compound, it is not converted to its biologically active metabolites in rodents, and thus we are unable to study its anti-glioma effects in our standard animal models. Nevertheless, its similarities in structure and activity to thalidomide warrant its investigation in patients with gliomas given the growing data on the activity of thalidomide in this patient population. Given the altered pharmacology seen in patients with gliomas secondary to concurrent cytochrome P450 altering medications (glucocorticoids, anti-epileptics) we feel it is prudent to proceed with a glioma specific phase I trial to complement other solid tumor phase I trials. Thus, we now propose a Phase I trial of CC-5013 in patients with recurrent gliomas.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with histologically proven high grade gliomas or patients with a clinical and radiogrphic diagnosis of brainstem glioma will be eligible for this protocol. These include glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), malignant glioma/astrocytoma NOS (not otherwise specified), primitive neuroectodermal tumors (PNET), meningioma, hemangioblastoma, ependymoma, or progressive glioma. Patients must have shown either, evidence for tumor recurrence or progression by CT, or (preferably) MRI scan performed within 21 days prior to registration or had biopsy proven recurrent glioma within the last 12 weeks prior to enrollment (in order to allow the enrollment of patients with recurrent gliomas who have undergone a complete radiographic resection and now have no radiographic evaluable disease). Patients having undergone recent resection of a recurrent or progressive tumor, will be eligible two weeks after surgery. Patients must have failed prior radiation therapy. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must be greater than or equal to 18 years old, and must have a life expectancy of greater than 8 weeks. Patients must have a Karnofsky performance status of greater than or equal to 60. Patients must be at least two weeks from radiation therapy. Additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide or carboplatin, 3 weeks from procarbazine, and 2 weeks from last vincristine administration. Patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen). Patients must have adequate bone marrow function (WBC greater than or equal to 2,300/l, platelet count of greater than or equal to 90,000/mm(3), and hemoglobin greater than or equal to 8 gm%), adequate liver function (SGOT and bilirubin less than 3 times the upper limit of normal), and adequate renal function (creatinine less than 2.0 mg/dL or creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. Patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registration. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with CC-5013. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner). EXCLUSION CRITERIA: Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases are ineligible. No concurrent use of other standard chemotherapeutics or investigative agents. Patients on rifampin are ineligible given the potential for significant drug interactions.
Total Enrollment: 80
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 020145; 02-C-0145
Study Start Date: March 6, 2002
Record last reviewed: February 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032214
Other Glioma Studies:
1. A Phase II Trial of Intravenous Cereport ® (Registered Trademark) (RMP-7) and Carboplatin in Childhood Brain Tumors
2. SU5416 to Treat Recurrent Brain Tumors
3. Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
4. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
5. A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy
Related Studies:
Other Glioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas
|
|
|
|
|
|
|
|
