2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Refractory Multiple Myeloma, Stage III Multiple Myeloma, Unspecified Adult Solid Tumor, Protocol Specific
In brief
Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor
Key facts
- Study ID
- NCT00028821
- Run by
- National Cancer Institute (NCI)
- People needed
- 60
- Starts
- 2002-01-01
- Last updated by the study team
- 2013-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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