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UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors Clinical research trials and UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors. UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects often get the best healthcare available for their UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors  UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Maryland Greenebaum 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 carboplatin may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with carboplatin in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of UCN-01 and carboplatin when administered in combination in patients with advanced solid tumors. - Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the antitumor effect of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 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. PROJECTED ACCRUAL: Approximately 3-30 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 metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer effective - Brain metastases allowed provided the following treatment requirements are met: - Asymptomatic or clinically stable disease after surgery or radiotherapy - No concurrent requirement for steroids or antiseizure medications - More than 2 weeks since prior therapy (e.g., surgery or CNS irradiation) for brain metastases - Recovered from prior therapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% 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/ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - See Radiotherapy - History of coronary artery disease allowed provided LVEF is at least 45% by MUGA or echocardiogram - No symptomatic cardiac disease Pulmonary: - History of pulmonary disease allowed provided FEV_1is at least 1 liter Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biological composition to study drugs - No prior severe allergic reaction to cisplatin or carboplatin - No insulin-dependent diabetes mellitus - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carmustine) and recovered Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - Prior radiotherapy to the mediastinum is allowed provided LVEF is at least 45% by MUGA or echocardiogram Surgery: - See Disease Characteristics Other: - No other concurrent investigational or commercial agents for malignancy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinEdelman, Study Chair, University of Maryland Greenebaum Cancer Center
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Additional Information:
Study ID Numbers: CDR0000069321; NCI-5533,MSGCC-0143
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036777
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Benzoylphenylurea in Treating Patients With Advanced Solid Tumors
2. Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
3. Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer
4. Combination Chemotherapy in Treating Patients With Advanced Cancer
5. Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
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UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
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