Status:
TERMINATED
Study of Atiprimod Treatment for Patients With Advanced Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Callisto Pharmaceuticals
Conditions:
Advanced Cancer
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
Primary Objectives: The primary objectives of this study are to identify the maximum tolerated dose (MTD) and to evaluate the safety of atiprimod when given in doses starting at 60 mg/day and ranging...
Detailed Description
Atiprimod was shown to slow or stop the growth of several human tumor cell lines in laboratory studies. Researchers believe it may have the same effect on tumor cells in patients with advanced cancer....
Eligibility Criteria
Inclusion
- Patient must have histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
- Patient must have an estimated life expectancy of at least 12 weeks.
- Patient must have measurable or evaluable disease.
- Patient has an ECOG (Zubrod) performance status of 0 to 2.
- Age \>/= 13 years at the time of signing informed consent.
- All necessary screening evaluations for determining eligibility must be obtained within 14 days prior to the first dose of study drug except for measurement of disease extent, which can be obtained within 28 days prior to the first dose of study drug.
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
- Patient must understand and voluntarily sign an informed consent document.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
Exclusion
- Renal insufficiency (serum creatinine levels \>/= 2 times the upper limit of normal).
- Concomitant radiotherapy, chemotherapy, or other investigational agents/therapies.
- Peripheral neuropathy of Grade 3 or greater assessed by a directed neurologic examination, including light touch, pinprick, proprioception, and deep tendon reflexes of the upper and lower extremities; and questioning for symptoms of paresthesia and numbness (FACT/GOG-Ntx: Appendix D).
- Patients with evidence of clinically significant mucosal or internal bleeding. (For example, a decrease in hemoglobin of greater than 1.5 gm will be considered clinically significant.)
- Patients with a platelet count \< 50,000 cells/mm\^3.
- Patients with an absolute neutrophil count (ANC) of \< 1000 cells/mm\^3.
- ALT/SGPT or AST/SGOT levels \>/= 2 times the upper limit of normal (ULN) except in patients with documented hepatic metastases.
- Total bilirubin \> 2 times the ULN.
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study. Such examples include infection requiring hospitalization and psychiatric health which would make compliance understanding difficult.
- Clinically relevant active infection or serious co-morbid medical conditions such as recent (\</6 months) MI, unstable angina, difficult to control CHF, uncontrolled HTN, difficult to control cardiac arrhythmias, COPD or chronic restrictive pulmonary disease, and cirrhosis. Examples of uncontrolled HTN and difficult to control cardiac arrhythmias include situations in which patients still have the problem while on medication or patients who have required \> two medication changes in the last 6 months in order to control the problem, or cardiac patients with a NYHA classification of \> Class II.
- If WCBP, pregnant, lactating, or not using adequate contraception.
- As atiprimod is a potent inhibitor of CYP2D6 (a chemical that is produced naturally by the body that processes and eliminates certain types of chemicals), patients taking drugs that are substrates of CYP2D6 (e.g., beta blockers, antidepressants, and antipsychotics; see Appendix G) will be excluded from the study.
- Received any form of radiotherapy, chemotherapy, or other investigational agents/therapies within 30 days prior to the first dose of study drug.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00430014
Start Date
March 1 2005
End Date
February 1 2012
Last Update
February 15 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030