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UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical research trials and UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors. UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "U" Clinical Trials Conditions > UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors  UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and irinotecan in patients with advanced solid tumors, primarily lung, ovarian, and gastrointestinal tumors. - Determine the acute and chronic toxicity profile of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the anti-tumor effect of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the recommended phase II dose. Patients are followed at 1 month. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 7-15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative therapy does not exist or is no longer effective - Gastrointestinal, lung, and ovarian malignancies are given priority - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months 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/ALT no greater than 2.5 times upper limit of normal (ULN) Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic coronary artery disease - No symptomatic cardiac dysfunction - No symptoms suggestive of coronary artery disease - LVEF at least 50% Pulmonary - No symptomatic pulmonary dysfunction - FEV_1 greater than 75% of predicted - DLCO greater than 75% of predicted Other - Amylase no greater than 2 times ULN - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No diabetes mellitus or random glucose more than 200 mg/dL - No prior allergic reaction attributed to compounds of similar biological or chemical composition to UCN-01 or irinotecan (including rash and systemic allergic reaction causing hypotension and respiratory distress) - No chronic diarrhea (more than 5 stools/day) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 14 days before, during, and for at least 30 days after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior UCN-01 and irinotecan allowed Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - No prior mediastinal radiation Surgery - Not specified Other - At least 14 days since prior warfarin - No concurrent warfarin unless required for maintaining patency of existing, permanent IV catheters - No concurrent commercial or other investigational anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RossDonehower, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Ross Donehower 410-955-8838
Additional Information:
Study ID Numbers: CDR0000257566; NCI-5528,JHOC-J0173
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047242
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
2. ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy
3. Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
4. Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
5. Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
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