| |
Protocol Number:
06-C-0226
- Title:
A Phase I Pharmacokinetic and Pharmacodynamic Study of Temsirolimus (CCI-779) in Patients with Advanced Malignancies and Normal and Impaired Liver Function: An NCI Organ Dysfunction Working Group Study
- Number:
06-C-0226
- Summary:
Background:
-Temsirolimus is an experimental drug that has shown activity against various tumor types in early clinical trials.
-Temsirolimus is cleared by the liver, therefore, this clinical trial is studying the doses that can be safely given to patients with advanced cancer and various degrees of liver dysfunction.
Objectives:
-To determine the highest dose of temsirolimus that can safely be given to patients with advanced cancer who have various degrees of liver impairment.
Eligibility:
-Patients with advanced inoperable solid tumors or lymphoid cancers for which standard or palliative measures do not exist or are no longer effective. Patients may have normal or abnormal liver function.
Design:
-Temsirolimus is given as an infusion through a vein over a 30-minute period weekly (on days 1, 8, 15 and 22 every 28 days). Treatment continues until the drug is no longer beneficial, there are intolerable side effects or until the patient decides to stop treatment.
-The drug dosage is increased in subsequent groups of 6 to 12 patients, as long as the side effects in the previous group were tolerated.
-Patients are evaluated weekly with a physical examination and blood tests and every 8 weeks with imaging tests (e.g., CT, ultrasound or MRI) to determine the response to treatment.
- Sponsoring Institute:
-
National Cancer Institute (NCI)
- Recruitment Detail
- Type:
No longer recruiting/follow-up only
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
-
Hepatic Dysfunction
-
Liver Disease
-
Advanced Cancer
-
Hepatic Impairment
-
Increased Liver Enzymes
- Recruitment Keyword(s):
-
Advanced Cancer
-
Solid Tumor
-
Lymphoma
-
Liver Dysfunction
- Condition(s):
-
Advanced Cancer
-
Liver Disease
- Investigational Drug(s):
-
Temsirolimus (CCI-779)
- Investigational Device(s):
- None
- Interventions:
-
Drug: Temsirolimus (CCI-779)
- Supporting Site:
-
National Cancer Institute
- Contact(s):
-
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
-
Frost P, Moatamed F, Hoang B, Shi Y, Gera J, Yan H, Frost P, Gibbons J, Lichtenstein A In vivo antitumor effects of the mTOR inhibitor CCI-779 against human multiple myeloma cells in a xenograft model. Blood. 2004 Dec 15;104(13):4181-7. Epub 2004 Aug 10
-
Sekulic A, Hudson CC, Homme JL, Yin P, Otterness DM, Karnitz LM, Abraham RT. A direct linkage between the phosphoinositide 3-kinase-AKT signaling pathway and the mammalian target of rapamycin in mitogen-stimulated and transformed cells. Cncer Res. 2000 Jul 1;60(13): a3504-13
-
Podsypanina K, Lee RT, Politis C, Hennessy I, Crane A, Puc J, Neshat M,Wang H,Yang L,GibbonsJ, Frost P, Dreisbach V, Blenis J, Gaciong Z, Fisher P, Sawyers C, Hedrick-Ellenson L, Parsons R. An inhibitor of mTOR reduces neoplasia and normalizes p70/S6 kinase activity in Pten+/- mice. Institute of Cancer GProc Natl Acad Sci U S A. 2001 Aug 28;98(18):10031-3.
If you have:
Search The Studies | Help | Questions |
Clinical Center Home | NIH Home
 National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
|
|
