2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors

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

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.

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

Details

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

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