Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Neuroendocrine Carcinoma Clinical Trial

Official title:

A Phase II Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388063
• Other study ID #: CP-106
• Secondary ID: WIRB 20061681
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2006
• Last updated: December 17, 2007
• Start date: October 2006
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: Callisto Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).

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 bidimensionally measurable disease. In the more recently reported ECOG phase III study of chemotherapy in carcinoid tumors (E1281), patients were randomly assigned to treatment with 5-fluorouracil (5FU) plus doxorubicin or 5FU plus streptozocin. The median progression free survival durations were disappointing. They were 4.5 months in the 5FU plus doxorubicin arm and 5.3 months in the 5FU plus streptozocin arm. Overall survival durations recorded in the trial were also suboptimal at 15 and 24 months respectively. There is no clear survival benefit for cytotoxic chemotherapy.

This is a phase II, multi-center, open-label study of 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) (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). A maximum of 40 evaluable patients will be enrolled in this study. Atiprimod will be administered orally as a single daily dose of 120 mg/day for 14 days, followed by a 14-day treatment-free period (i.e., 1 treatment cycle = 28 days).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma

Intervention

Drug:
• Atiprimod
oral, 14 days on / 14 days off; 30mg capsules

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	Robert H. Lurie Comprehensive Cancer Center of Northwestern	Chicago	Illinois
United States	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	Mount Sinai Medical Center	New York	New York
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Scott and White Memorial Hospital, Scott Sherwood and Brindley Facility	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Callisto Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of symptoms (diarrhea, flushing and/or wheezing)		1 year	No
Primary	Progression of neuroendocrine tumor(s)		1 year	No
Secondary	Adverse events		1 year	Yes