Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
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
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed