Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors. * Determine the pharmacokinetic profile of this drug in these patients. * Estimate the starting dose of this drug for subsequent phase II efficacy studies. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity. Patients are followed at 30 days. PROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.
Interventions
DRUGS-3304
Sponsors
Roswell Park Cancer Institute
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 that failed to respond or relapsed after prior therapy or for which no standard therapy exists * Biopsy-accessible lesion * No brain metastasis unless clinically stable and off therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 6 weeks Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * Transaminases less than 2.5 times ULN Renal: * Creatinine less than 2.0 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 30 days after study * Able to tolerate oral medication * HIV negative * No AIDS * No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease) * No other serious concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses * No other concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * At least 4 weeks since prior hormonal therapy * Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses * No concurrent hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * No prior significant gastric resection Other: * Recovered from prior therapy * At least 4 weeks since other prior investigational antitumor drugs * No other concurrent investigational antitumor drugs * Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses
Countries
United States
Outcome results
None listed