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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Carcinoma

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Trial Information

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


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).


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Reduction of symptoms (diarrhea, flushing and/or wheezing)

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Gary Jacob, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Callisto Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CP-106

NCT ID:

NCT00388063

Start Date:

October 2006

Completion Date:

September 2007

Related Keywords:

  • Neuroendocrine Carcinoma
  • Neuroendocrine
  • Carcinoma
  • Atiprimod
  • Carcinoid
  • Carcinoma
  • Carcinoma, Neuroendocrine

Name

Location

Mount Sinai Medical CenterNew York, New York  10029
Hematology Oncology Services of ArkansasLittle Rock, Arkansas  72205
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Lahey ClinicBurlington, Massachusetts  01805
Cedars Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California  90048
Robert H. Lurie Comprehensive Cancer Center of NorthwesternChicago, Illinois  60611
Scott and White Memorial Hospital, Scott Sherwood and Brindley FacilityTemple, Texas  76508