2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 2-Methoxyestradiol; Estradiol

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor that is clinically unresectable

• No known standard therapy that is potentially curative or definitely capable of extending life expectancy

• Patients with multiple myeloma may be enrolled to expansion cohort once the recommended phase II dose is established

• Tumor amenable to serial biopsy

• No bone metastases as only site of disease

• No CNS metastases

• Performance status - ECOG 0-2

• At least 12 weeks

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10.0 g/dL

• Bilirubin normal

• AST no greater than 2.5 times upper limit of normal (ULN)

• Creatinine no greater than 1.5 times ULN

• No New York Heart Association class III or IV heart disease

• Adequate oral intake

• No malabsorption syndrome

• No disease of terminal small bowel

• No dysphagia or other condition that would interfere with ability to swallow intact capsules

• No clinical contraindications (e.g., anticoagulant therapy) to biopsy

• No uncontrolled infection

• No seizure disorder

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• More than 4 weeks since prior biologic therapy

• More than 4 weeks since prior immunotherapy

• No concurrent immunotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No concurrent chemotherapy

• No concurrent megestrol

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to more than 25% of bone marrow

• No concurrent radiotherapy

• No prior extensive resection of terminal small bowel

• No prior major resection of the stomach or proximal small bowel

• No other concurrent ancillary investigational therapy