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Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors Clinical research trials and Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors. Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors clinical trial. Participants frequently get the best healthcare available for their Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors  Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. PURPOSE: Randomizedphase I trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have metastatic or unresectablesolid tumors.
Details: OBJECTIVES: - Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors. - Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients. - Determine the toxicity of this regimen in these patients. - Determine the observed antitumor response in patients treated with this regimen. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28. - Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12 patients (6 per treatment arm) 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 malignant solid tumor - Metastatic or unresectable - Standard curative or palliative therapy is no longer effective or does not exist - Measurable or assessable disease - No uncontrolled brain metastases - Patients with brain metastases are eligible provided the following are true: - Stable neurologic status - At least 4 weeks since prior steroids or anticonvulsants - No neurologic dysfunction that would confound evaluation PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - More than 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal - No history of inflammatory bowel disease requiring therapy - No chronic diarrhea syndromes - No paralytic ileus Other - Not pregnant or nursing - Negative pregnancy test - Fertile female patients must use 2 forms of effective contraception, including 1 highly effective method, for at least 4 weeks before, during, and for 4 weeks after study participation - Male patients must use effective barrier contraception during and for 4 weeks after study participation - No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs - No uncontrolled seizure disorder - No other concurrent uncontrolled illness that would preclude study participation - No psychiatric illness or social situation that would preclude study compliance - No ongoing or active infection - No significant traumatic injury within the past 28 days - No serious, nonhealing wounds or ulcers - No bone fractures - No preexisting peripheral neuropathy grade 2 or greater 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 or mitomycin) Endocrine therapy - See Disease Characteristics Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - More than 28 days since prior major surgical procedure or open biopsy Other - At least 4 weeks since prior investigational therapy - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial agents or therapies for the malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ApurvaDesai, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Apurva Desai 773-702-9200
Additional Information:
Study ID Numbers: CDR0000304517; UCCRC-12044B,NCI-5814
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062127
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
2. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
3. Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors
4. UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
5. Irinotecan in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Illinois Clinical Trials
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Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
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