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A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas Clinical research trials and A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas. A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas  A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas
A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas
For Condition: Glioma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study examines the use of CC-8490, which has been demonstrated as having significant preclinical activity, in patients who have gliomas that recur or that are resistant to treatment, or both. Malignant gliomas-tumors arising from tissue that is mingled with essential parts of nervous tissue-are a major cause of cancer-related illness and death in the United States. These tumors are the second leading cause of cancer in people under the age of 35 and the fourth leading cause in those under age 54. Although the cause of the disease is unknown, there is speculation about a genetic tendency, chemical causes, or viral causes. Recent research suggests a significant increase in the incidence of malignant gliomas, particularly in elderly people. Despite recent advances in techniques of neuroimaging, neuroanesthesia, and neurosurgery, the prognosis for patients with malignant gliomas treated by surgical removal alone remains low. These gliomas show unique ability to infiltrate and grow, making a total removal impossible without causing unacceptable neurological damage to the patient. Most important, however, is that gliomas tend to have essential resistance to most standard anticancer agents. Thus, new such agents are needed, and a Phase I trial that escalates the dose of CC-8490 is proposed. Researchers have noted that high doses of tamoxifen had effects against the proliferation activity of cultured gliomas cells. Consequently, there is interest in finding more powerful agents called selective estrogen receptor modulators, or SERMS. CC-8490 has a specific way of acting on the ERa receptor and inhibits the rapid increase of MCF-7 human breast carcinoma cells. CC-8490 also acts against the proliferation of glioblastoma cells, independent of estrogen receptor binding. Patients 18 years of age and older with malignant gliomas who have shown recurrence or progression of a tumor and who failed previous radiation therapy may be eligible for this study. Participants will take CC-8490 once daily on an every-4-week cycle, with no breaks in between, and will be given increasingly higher doses until a maximum tolerated dose is established. Dose levels begin at 500 mg and escalate by levels of 500 mg, to a total of 2500 mg. In addition, participants will undergo the following procedures and tests: - History, physical, and neurological examination every 2 weeks for the first cycle and every 4 weeks after that. - Blood tests, including complete blood count, and differential and platelet count obtained every 2 weeks. - Tests for various chemistries every 2 weeks for the first 2 cycles and then every 4 weeks; tests for calcium, phosphorous, magnesium, and uric acid performed before each cycle. - Magnetic resonance imaging or computed tomography performed every 4 weeks.
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. Preclinical and clinical data have demonstrated that Tamoxifen has anti-glioma activity and is now commonly used in the treatment of patients with these malignant tumors. Although well tolerated, Tamoxifen has shown only minimal overall activity in the clinic prompting us to search for other agents that may work along the same pathway. We have demonstrated that CC-8490, which was originally investigated as a selective estrogen receptor modulator (SERM), has significant preclinical anti-glioma activity, independent of ER binding, in vitro and in vivo with an excellent safety profile in normal human volunteers. Thus, we now propose a Phase I trial of CC-8490 in patients with recurrent/refractory gliomas.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with histologically proven supratentorial malignant gliomas 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). Also included will be radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy. Other CNS tumor histologies will not be eligible for this trial. 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, as stated above, will be eligible two weeks after surgery. Patient must have failed prior radiation therapy and must have an interval of greater than or equal to 2 weeks from the completion of radiation therapy to study entry. All patients must sign an informed consent, or if cognitively impaired, their assigned DPA, 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 greater than 8 weeks. Patients must have a Karnofsky performance status of greater than or equal to 60. 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 (granulocyte count greater than or equal to 1500/mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 8 gm%), adequate liver function (total bilirubin less than or equal to 1.5 mg/dL, AST/ALT less than or equal to 2 x ULN), and adequate renal function (creatinine less than or equal to 1.5 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. Eligibility level for platelets may not 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) are ineligible, unless they are in complete remission and off all therapy for that disease for a minimum of 3 years. 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-8490. Women of childbearing potential (WCBP) who are sexually active 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). Patients must be able to swallow capsules whole. EXCLUSION CRITERIA: Patients who, in the view of the treatment physician, have significant active cardiac, hepatic, renal, or psychiatric diseases that would significantly increase the risk of using CC-8490 are ineligible. Concurrent use of other standard chemotherapeutics or investigative agents. Pregnant or lactating females. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, obscures the evaluation of toxicity or alters drug metabolism. Use of other experimental study drug within 28 days of registration. Patients who are pregnant or breastfeeding.
Total Enrollment: 35
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040035; 04-C-0035
Study Start Date: October 20, 2003
Record last reviewed: October 15, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071864
Other Glioma Studies:
1. SU5416 to Treat Recurrent Brain Tumors
2. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
3. OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy
4. A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX)
5. Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas
Related Studies:
Other Glioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas
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