UCN-01 and Prednisone in Treating Patients With Solid Tumors or Lymphoma
RATIONALE: UCN-01 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining UCN-01 with prednisone may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with prednisone in treating patients who have refractory solid tumors or lymphoma.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas|
|Study Start Date:||June 2002|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of UCN-01 in combination with prednisone in patients with refractory solid tumors or lymphomas.
- Determine the toxic effects of this regimen in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
- Assess any tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of UCN-01.
Patients receive oral prednisone daily on days 1-5 and UCN-01 IV over 36-72 hours on days 3-5. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the recommended phase II dose.
Patients are followed every 3-12 months for 5 years.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 18 months.
|United States, Maryland|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Frederick Cancer Research and Development Center|
|Frederick, Maryland, United States, 21702-1201|
|Study Chair:||Giovanni Melillo, MD||National Cancer Institute - Frederick|