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Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

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.
 
ClinicalTrials.gov Identifier: NCT00165230
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2009
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date April 28, 2009
Study Start Date  ICMJE May 2002
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00165230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • To evaluate overall response and progression free survival of this patient population
  • to evaluate the safety of temodar and thalidomide.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
Official Title  ICMJE A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumor
Intervention  ICMJE
  • Drug: Thalidomide
  • Drug: Temodar
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
32
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165230
Other Study ID Numbers  ICMJE 02-011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
Investigators  ICMJE
Principal Investigator: Matthew H. Kulke, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP