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Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

Primary Purpose

Neuroendocrine Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Temodar
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumor focused on measuring thalidomide, temodar, metastatic neuroendocrine tumor, unresectable neuroendocrine tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma Prior treatment with chemoembolization or cryotherapy is allowed Radiotherapy is allowed if completed more than 4 weeks prior to study. Measurable disease as defined by RECIST criteria Age greater than or equal to 18 years. ECOG performance status of less than or equal to 2 ANC >1,500/mm3 Platelet Count > 100,000/mm3 Hemoglobin > 9 g/dl Serum creatinine < 1.5 x ULN Total bilirubin < 2 x ULN SGOT and SGPT < 2 x ULN Alkaline phosphatase < 2 x ULN Life expectancy of greater than 12 weeks Exclusion Criteria: Clinically symptomatic central nervous system metastases or carcinomatous meningitis Myocardial infarction in past 6 months Major surgery in past two weeks Uncontrolled serious medical or psychiatric illness Insufficient recovery from all active toxicities of prior therapies Active nonmalignant systemic disease Frequent vomiting or medical condition that could interfere with oral medication intake Known HIV positivity or AIDS-related illness Pregnant or nursing women

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconness Medical Center

Outcomes

Primary Outcome Measures

To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.

Secondary Outcome Measures

To evaluate overall response and progression free survival of this patient population
to evaluate the safety of temodar and thalidomide.

Full Information

First Posted
September 9, 2005
Last Updated
April 27, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00165230
Brief Title
Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
Official Title
A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.
Detailed Description
Patients will receive thalidomide orally once daily continuously unless they experience significant side effects. Temodar is given orally once a day for one week, followed by a one week break period. This one week on/one week off schedule will continue for the duration of treatment unless there are significant side effects. After eight weeks (2 cycles) a CT scan will be performed to see how the treatment has affected the patient's tumor. Patients will continue taking the study drug unless there is evidence of tumor growth. Regular blood tests will be done weekly during the first two months to make sure that the treatment is not resulting in serious side effects. If there are no side effects during the first two months, the blood tests may decrease in frequency to every two weeks. Immediately after the patient has completed the study they will be evaluated by physical exam, blood work, and a CT scan. The follow-up will consist of clinic visits and phone calls every 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor
Keywords
thalidomide, temodar, metastatic neuroendocrine tumor, unresectable neuroendocrine tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Type
Drug
Intervention Name(s)
Temodar
Primary Outcome Measure Information:
Title
To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Secondary Outcome Measure Information:
Title
To evaluate overall response and progression free survival of this patient population
Title
to evaluate the safety of temodar and thalidomide.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma Prior treatment with chemoembolization or cryotherapy is allowed Radiotherapy is allowed if completed more than 4 weeks prior to study. Measurable disease as defined by RECIST criteria Age greater than or equal to 18 years. ECOG performance status of less than or equal to 2 ANC >1,500/mm3 Platelet Count > 100,000/mm3 Hemoglobin > 9 g/dl Serum creatinine < 1.5 x ULN Total bilirubin < 2 x ULN SGOT and SGPT < 2 x ULN Alkaline phosphatase < 2 x ULN Life expectancy of greater than 12 weeks Exclusion Criteria: Clinically symptomatic central nervous system metastases or carcinomatous meningitis Myocardial infarction in past 6 months Major surgery in past two weeks Uncontrolled serious medical or psychiatric illness Insufficient recovery from all active toxicities of prior therapies Active nonmalignant systemic disease Frequent vomiting or medical condition that could interfere with oral medication intake Known HIV positivity or AIDS-related illness Pregnant or nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew H. Kulke, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

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