2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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RATIONALE: 2-Methoxyestradiol may stop the growth of cancer 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.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors. Determine the side effect profile of this drug in these patients. Determine the pharmacokinetic profile of this drug in these patients. Determine the changes in positron-emission tomography scans of patients treated with this drug. Determine the changes in apotosis in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at day 30. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.

Official Title
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A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: 2-methoxyestradiol


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed solid tumor Metastatic or unresectable disease for which standard curative treatments do not exist or are no longer effective Clinically progressive disease documented by any of the following: New area of malignant disease Progression of soft-tissue metastases At least 1 new metastatic deposit on technetium Tc 99m bone scintigraphy Increases in prostate-specific antigen Lesions accessible for serial biopsy No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No other concurrent uncontrolled illness No ongoing or active infection No prior allergic reactions to compounds of similar chemical or biological composition to 2-methoxyestradiol No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carboplatin) No concurrent chemotherapy for cancer Endocrine therapy: Luteinizing-hormone releasing-hormone agonist therapy must be continued for patients with prostate cancer except those with prior orchiectomy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy for cancer Surgery: See Endocrine therapy Other: Recovered from prior therapy No other concurrent therapy for cancer No concurrent combination antiretroviral therapy for HIV-positive patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 2-methoxyestradiol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific