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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 Metastatic or Unresectable Solid Tumors

2. Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors

3. PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors

4. KRN7000 in Treating Patients With Solid Tumors

5. Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors

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