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CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy conditions. Clinical Trials Search.org is a website dedicated 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 health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, 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 allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid 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. Human subjects frequently get the finest healthcare available for their CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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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. Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
2. CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
3. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
4. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
5. XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma
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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