2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
Refractory Multiple Myeloma, Stage III Multiple Myeloma, Unspecified Adult Solid Tumor, Protocol Specific

About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: 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 Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Bilirubin normal AST no greater than 2.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN No New York Heart Association class III or IV heart disease 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 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 More than 4 weeks since prior biologic therapy More than 4 weeks since prior immunotherapy No concurrent immunotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No concurrent chemotherapy No concurrent megestrol More than 4 weeks since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy No prior extensive resection of terminal small bowel No prior major resection of the stomach or proximal small bowel No other concurrent ancillary investigational therapy
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (2-methoxyestradiol)
Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.