Protocol Number: 01-C-0256

Title:

Phase I Trial of 2-Methoxyestradiol (2ME2), (NSC-659853) an Angiogenesis Inhibitor, in Patients with Solid Tumors

Number:

01-C-0256

Summary:

This study will determine the safest dose of 2-methoxyestradiol (2-ME2) that can be given to cancer patients. 2-ME2 has reduced the growth of both primary and metastatic (spreading) human tumors in mice. The drug is thought to prevent or slow the growth of blood vessels that supply tumors.

Patients 18 years of age or older with a solid tumor cancer that has spread from the primary site or cannot be removed surgically and for which standard treatments are no longer effective may be eligible for this study. Patients with metastatic brain tumors are excluded. Candidates will be screened with studies such as computed tomography (CT) scans to determine the extent of spread of the cancer, blood and urine tests. This evaluation may take up to 2 weeks to complete.

Participants will be hospitalized for the first dose of 2-ME2. This dose will be followed by blood sampling (about 14 samples of 1 teaspoon each over 2 days) to determine how much of the drug enters the blood. Patients will then take 2-ME2 at home twice a day for 6 months or more, depending on their response to the drug. They will be followed at NIH every 2 weeks for 12 weeks after starting therapy and then monthly. In addition, participants will undergo the following procedures:

Biopsies-removal of a small piece of tumor for study under the microscope-are done before starting therapy and again after 1 to 2 months.

Standard X-rays are taken before starting therapy and then every 2 months.

Computed tomography (CT) scans, which use X-rays to provide 3-dimensional images of the part of the body being studied, are done after 2 months and then every 2 months.

Positron emission tomography (PET), a test are similar to CT, but which uses an injected or ingested radioactive material to produce images, is done before starting therapy and several months later. PET scans can help determine if 2-ME is blocking blood vessel growth to the tumor.

Blood tests are done with each clinic visit to determine the effects of 2-ME2 on blood counts and liver and kidney function, and then monthly to measure the concentration of the drug in the body and look for factors associated with the cancer.

Some patients may also have magnetic resonance imaging (MRI), which uses radio waves and a magnetic field to produce images of the structure and function of various tissues; ultrasound (using sound waves to produce images); or a bone scan to measure tumor extent.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Patients with solid tumors are eligible to participate. Protocol does not include healthy volunteers.

Disease Category:

PROTICD

Keywords:

Angiogenesis

Refractory Cancer

Pharmacokinetic

Molecular Endpoints

PET Imaging

Recruitment Keywords:

Tumor

Metastatic Cancer

Solid Tumor

Conditions:

Pathologic Angiogenesis

Neoplasm

Investigational Drug(s):

2ME2

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Quantitative relationships of intravascular tumor cells, tumor vessels, and pulmonary metastases following tumor implantation

Potent antitumor activity of 2-methoxyestradiol in human pancreatic cancer cell lines

Inhibition of normal and experimental angiotumor endothelial cell proliferation and cell cycle progression by 2-methoxyestradiol

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/19/2004