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| Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028821 |
Purpose
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.
| Condition | Intervention | Phase |
|
Multiple Myeloma and Plasma Cell Neoplasm Unspecified Adult Solid Tumor, Protocol Specific |
Drug: 2-methoxyestradiol |
Phase I |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Multiple Myeloma |
| Drug Information available for: | 2-Methoxyestradiol |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I and Pharmacologic Study of 2-Methoxyestradiol in Patients With Advanced Solid Tumors |
| Study Start Date: | January 2002 |
OBJECTIVES:
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor that is clinically unresectable
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Minnesota | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| Mayo Clinic |
| National Cancer Institute (NCI) |
| Study Chair: | Charles Erlichman, MD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069137, MAYO-MC0017, NCI-3356 |
| First Received: | January 4, 2002 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028821 |
| Health Authority: | United States: Federal Government |
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