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

This study has been completed.
Sponsor:
Information provided by:
Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00388063
First received: October 11, 2006
Last updated: December 17, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Progression of neuroendocrine tumor(s) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gary Jacob, Callisto Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00388063     History of Changes
Other Study ID Numbers: CP-106, WIRB 20061681
Study First Received: October 11, 2006
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014