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Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Irinotecan Plus Mitomycin 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 Plus Mitomycin in Treating Patients With Advanced Solid Tumors Clinical research trials and Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors. Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors  Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors
Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): San Antonio Cancer Institute ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus mitomycin in treating patients who have advanced solid tumors that are persistent or recurrent.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of mitomycin when administered with irinotecan in patients with advanced solid tumors. II. Determine whether the pharmacokinetic profile of irinotecan is altered by prior administration of mitomycin in this patient population. III. Determine the effect of irinotecan and mitomycin on the expression of DT-Diaphorase and the Topo I gene. IV. Determine the preliminary antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive mitomycin IV over 20 to 30 minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2 weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. Patients are followed for 1 month. PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced solid tumors for which no standard therapy exists or that is persistent or recurrent following prior therapy - Measurable or evaluable disease - No hematologic malignancies (e.g., leukemia or lymphoma) - No known brain or leptomeningeal disease (unless lesions have been irradiated, are currently untreated with corticosteroids, and have no clinical symptoms) --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy and recovered - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered; No prior mitomycin, irinotecan, or nitrosoureas; No more than 6 courses of chemotherapy containing an alkylating agent; No more than 4 courses of carboplatin - Endocrine therapy: At least 4 weeks since prior endocrine therapy and recovered - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No prior radiotherapy to more than 20% of bone marrow; No prior whole pelvis radiotherapy - Surgery: Not specified - Other: No concurrent phenytoin, phenobarbital, valproic acid, or other antiepileptic prophylaxis; No concurrent warfarin --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2; Karnofsky 70-100% - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 9 g/dL - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); AST and ALT less than 3 times ULN - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min; Calcium no greater than 12 mg/dL - Cardiovascular: No myocardial infarction within 6 months; No congestive heart failure requiring therapy; No unstable angina - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active infection No other concurrent severe disease; No psychiatric disorders; No history of seizure disorders; No uncontrolled diabetes (blood sugar no greater than 200 mg/dL)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldDrengler, Study Chair, San Antonio Cancer Institute
San Antonio Cancer Institute
San Antonio, Texas, 78229
United States
Additional Information:
Study ID Numbers: CDR0000066818; UTHSC-9785011214,NCI-V98-1504,P-UPJOHN-966475090,SACI-IDD-98-01
Study Start Date: May 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003710
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
2. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
3. High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
4. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
5. VNP20009 in Treating Patients With Advanced Solid Tumors
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Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors
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