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CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy Clinical research trials and CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy. CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy clinical trial. Subjects often receive the most expert healthcare possible for their CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy  CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
For Condition: adult solid tumor,small intestine cancer,Leukemia,Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
Details: OBJECTIVES: - Determine the maximum tolerated dose of CC-5013 in patients with refractory solid tumors and/or lymphoma. - Characterize the pharmacokinetic profile of this drug in these patients. - Determine whether any correlations can be made between plasma concentrations of this drug and toxicity or clinical activity or biological activity in these patients. - Characterize the side effect profile of this drug in these patients. - Determine the dose-limiting toxicity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral CC-5013 on day 1. Within 4-10 days, patients begin second course and receive oral CC-5013 once daily on days 1-21. Subsequent courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 3-51 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed refractory solid tumor and/or lymphoma - No brain metastases or primary CNS malignancies PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - ALT and AST less than 2.5 times normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No unstable or newly diagnosed angina pectoris - No myocardial infarction within the past 6 months - No New York Heart Association class II, III, or IV congestive heart failure Pulmonary: - No chronic obstructive lung disease requiring oxygen therapy Other: - No uncontrolled seizures - No concurrent acute critical illness - No serious untreated infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or carboplatin) - No concurrent cytotoxic chemotherapy Endocrine therapy: - At least 4 weeks since prior hormonal therapy - Concurrent luteinizing hormone-releasing hormone agonist required in patients with prostate cancer unless prior orchiectomy has been performed Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Endocrine therapy - Prior surgery allowed Other: - Recovered from prior therapy - No concurrent anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine) - No concurrent rifampin - No concurrent grapefruit juice
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamDahut, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Center for Cancer Research *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Kathy Fedenko 800-569-6219 ext. 67166
Additional Information:
Study ID Numbers: CDR0000069241; NCI-02-C-0083
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031941
Other Adult Solid Tumor Studies:
1. PS-341 in Treating Patients With Advanced Cancer
2. 506U78 in Treating Patients With Lymphoma
3. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
4. Donor Stem Cell Transplantation in Treating Patients With Relapsed Hematologic Cancer
5. Clofarabine in Chronic Lymphocytic Leukemia
Related Studies:
Other adult solid tumor Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
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