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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
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 |
| 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
More Information
| Study ID Numbers: | CDR0000069137, MAYO-MC0017, NCI-3356 |
| Study First Received: | January 4, 2002 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028821 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma stage III multiple myeloma unspecified adult solid tumor, protocol specific |
|
Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Estrogens Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Hematologic Diseases Mitosis Modulators Vascular Diseases Antimitotic Agents Estradiol Pharmacologic Actions Multiple Myeloma Neoplasms 2-methoxyestradiol Tubulin Modulators Lymphoproliferative Disorders Neoplasms, Plasma Cell |