ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy
RATIONALE: ILX23-7553 may help solid tumor cells develop into normal cells.
PURPOSE: Phase I trial to study the effectiveness of ILX23-7553 in treating patients who have solid tumors that have not responded to previous therapy.
|Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: vitamin D3 analogue ILX23-7553||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Oral ILX23-7553 in Patients With Solid Tumors|
|Study Start Date:||October 1999|
|Study Completion Date:||December 2009|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of ILX23-7553 in patients with refractory solid tumors. II. Determine the principal and dose limiting toxicities of this treatment regimen in terms of duration and reversibility in this patient population. III. Determine the preliminary evidence of antitumor activity with this treatment regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients receive oral ILX23-7553 for 5 days. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ILX23-7553 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 10 patients experience dose limiting toxicity. Patients are followed monthly for at least 2 months.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study within 12-18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004926
|United States, New Jersey|
|New Jersey Medical School|
|Newark, New Jersey, United States, 07103-2714|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Steven Soignet, MD||Memorial Sloan Kettering Cancer Center|