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2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors Clinical research trials and 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "2" Clinical Trials Conditions > 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors  2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
For Condition: stage 3 multiple myeloma,refractory plasma cell neoplasm,unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the optimal biologic dose and/or maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors. - Determine the qualitative and quantitative toxic effects of this drug in these patients. - Determine the pharmacokinetics and metabolism of this drug in these patients. - Determine the biologic changes within the tumor of these patients when treated with this drug. - Correlate the pharmacokinetics and toxicity of this drug in these patients. - Evaluate the biologic evidence of angiogenesis inhibition in patients receiving this drug. - Correlate genetic polymorphisms in cytochrome P450 and sulfotransferases isoforms with the pharmacokinetics of this drug. OUTLINE: This is a dose-escalation study. Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 2-ME until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 42-60 patients will be accrued for this study within 19 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is clinically unresectable - No known standard therapy that is potentially curative or definitely capable of extending life expectancy - Patients with multiple myeloma may be enrolled to expansion cohort once the recommended phase II dose is established - Tumor amenable to serial biopsy - No bone metastases as only site of disease - No CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic: - Bilirubin normal - AST no greater than 2.5 times upper limit of normal (ULN) Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease Gastrointestinal: - Adequate oral intake - No malabsorption syndrome - No disease of terminal small bowel - No dysphagia or other condition that would interfere with ability to swallow intact capsules Other: - No clinical contraindications (e.g., anticoagulant therapy) to biopsy - No uncontrolled infection - No seizure disorder - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy - No concurrent immunotherapy Chemotherapy: - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No concurrent chemotherapy Endocrine therapy: - No concurrent megestrol Radiotherapy: - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow - No concurrent radiotherapy Surgery: - See Disease Characteristics - No prior extensive resection of terminal small bowel - No prior major resection of the stomach or proximal small bowel Other: - No other concurrent ancillary investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesErlichman, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Charles Erlichman 507-284-4918
Additional Information:
Study ID Numbers: CDR0000069137; MAYO-MC0017,NCI-3356
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028821
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Cancer
2. Study to Assess Cancer Patients' Satisfaction With Hospital Quality of Care
3. PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
4. CP-609,754 in Treating Patients With Advanced Solid Tumors
5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
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