|
Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma 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 Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma Clinical research trials and Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma 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 Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma. Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma 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 Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma clinical trial. Participants frequently get the best healthcare available for their Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma 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.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma  Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
For Condition: Leukemia,small intestine cancer,adult solid tumor,Lymphoma
Status: Completed
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup. PURPOSE: Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma.
Details: OBJECTIVES: - Classify patients with solid tumors or lymphoma according to UGT1A1 promoter (TATA box) and coding region (Gly71Arg) mutation, and CYP3A4 promoter (G to A) polymorphisms. - Identify UGT1A1 enzyme glucuronidator and irinotecan oxidizer phenotypes in these patients and determine the correlation between the two metabolic reactions in vivo. - Determine the relationship between UGT1A1 genotype (promoter and/or coding region mutation) and CYP3A4 promoter genotype vs gastrointestinal or bone marrow toxicity, and pharmacokinetics of irinotecan in these patients. - Determine the pharmacokinetics of irinotecan in these patients. OUTLINE: Patients are genotyped for UGT1A1 enzyme and classified as "Gilbert's" (7/7), "heterozygotes" (6/7), and "homozygotes for allele 6" (6/6). The DNA is analyzed for the UGT1A1 coding region mutation (Gly71Arg) and CYP3A4 promoter polymorphism. Patients are also examined for glucuronidator ratio of SN-38, the active metabolite of irinotecan, and classified as "low/slow" (very low or zero SN-38G/SN-38 ratio), "intermediate" (less than 50% normal ratio), or "normal". Patients receive irinotecan IV over 90 minutes once every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven solid tumor or lymphoma - Responded to irinotecan OR no existing curative therapy - No leukemia - Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3500/mm^3 - Absolute neutrophil count at least 1500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - SGOT/SGPT less than 5 times upper limit of normal (unless due to disease) Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No inflammatory bowel disease requiring therapy - No chronic diarrhea syndrome or paralytic ileus PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 2 weeks since prior colony stimulating factor - At least 4 weeks since prior biologic therapy - No concurrent biologic therapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow - No concurrent palliative radiotherapy Surgery: - No prior transplant Other: - No concurrent substrates of UGT1A1 enzyme - No concurrent inducers or inhibitors of UGT1A1 enzyme activity
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkRatain, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Additional Information:
Study ID Numbers: CDR0000067173; UCCRC-T98-0039,UCCRC-L97-0270,NCI-T98-0039
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003970
Other Adult Solid Tumor Studies:
1. A Phase I Study of a Histone Deacetylase Inhibitor, MS-275, with an Oral 28-Day Dosing Schedule in Refractory Solid Tumors and Lymphomas
2. Peripheral Blood Lymphocyte Therapy to Prevent Lymphoproliferative Disorders Caused by Epstein-Barr Virus in Patients Who Have Undergone Transplantation
3. Arsenic Trioxide to Treat Children with Leukemia or Lymphoma
4. Biological Therapy in Treating Patients With Lymphoma or Lymphoproliferative Disease
5. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
Related Studies:
Other adult solid tumor Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
|
|
|
|
|
|
|
|
