Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
Completed · Phase 2
Conditions studied: Neuroendocrine Carcinoma
In brief
This study will evaluate the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).
Key facts
- Study ID
- NCT00388063
- Run by
- Callisto Pharmaceuticals
- People needed
- 55
- Starts
- 2006-10-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2007-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient must have documented histologic proof of low or intermediate grade neuroendocrine carcinoma. Both carcinoid (any site; atypical/intermediate grade carcinoid is allowed) and islet cell (pancreatic endocrine tumor) will be eligible. Patient with neuroendocrine tumors associated with MEN1 syndrome will be eligible.
- Patients must have either metastatic or unresectable local-regional cancer. Patients with brain metastases are allowed on study, but they must have evaluable target lesions elsewhere.
- Patients must have measurable disease, as defined by RECIST.
- Patients must have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s) (defined as the appearance of one or more new lesions or a 20% increase in the sum of the longest diameter of target lesions during the 6 months prior to enrollment).
Where it is running
- Hematology Oncology Services of Arkansas — Little Rock, Arkansas, United States
- Cedars Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
- Robert H. Lurie Comprehensive Cancer Center of Northwestern — Chicago, Illinois, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- Mount Sinai Medical Center — New York, New York, United States
- Scott and White Memorial Hospital, Scott Sherwood and Brindley Facility — Temple, Texas, United States
Full record on ClinicalTrials.gov
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