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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388063
First Posted: October 13, 2006
Last Update Posted: December 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Callisto Pharmaceuticals
  Purpose
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).

Condition Intervention Phase
Neuroendocrine Carcinoma Drug: Atiprimod Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Callisto Pharmaceuticals:

Primary Outcome Measures:
  • Reduction of symptoms (diarrhea, flushing and/or wheezing) [ Time Frame: 1 year ]
  • Progression of neuroendocrine tumor(s) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 1 year ]

Enrollment: 55
Study Start Date: October 2006
Study Completion Date: September 2007
Intervention Details:
    Drug: Atiprimod
    oral, 14 days on / 14 days off; 30mg capsules
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 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388063


Locations
United States, Arkansas
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Cedars Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Texas
Scott and White Memorial Hospital, Scott Sherwood and Brindley Facility
Temple, Texas, United States, 76508
Sponsors and Collaborators
Callisto Pharmaceuticals
Investigators
Study Director: Gary Jacob, Ph.D. Callisto Pharmaceuticals
  More Information

Responsible Party: Gary Jacob, Callisto Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00388063     History of Changes
Other Study ID Numbers: CP-106
WIRB 20061681
First Submitted: October 11, 2006
First Posted: October 13, 2006
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Callisto Pharmaceuticals:
Neuroendocrine
Carcinoma
Atiprimod
Carcinoid

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue