Status:
COMPLETED
Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
Lead Sponsor:
Callisto Pharmaceuticals
Conditions:
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 an...
Detailed Description
For carcinoid, despite the many cytotoxic chemotherapy trials that have been conducted, no regimen has demonstrated a response rate of more than 20% using the criterion of a 50% reduction of bidimensi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00388063
Start Date
October 1 2006
End Date
September 1 2007
Last Update
December 21 2007
Active Locations (8)
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1
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
2
Cedars Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
3
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
4
Robert H. Lurie Comprehensive Cancer Center of Northwestern
Chicago, Illinois, United States, 60611