Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

This study has been completed.

Sponsor:

Collaborators:

Brigham and Women's Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Information provided by:

Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00165230

First received: September 9, 2005

Last updated: April 27, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

April 27, 2009

Start Date ^ICMJE

May 2002

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Neuroendocrine Tumor

Intervention ^ICMJE

Drug: Thalidomide
Drug: Temodar

Study Arm (s)

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

Completion Date

July 2006

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00165230

Other Study ID Numbers ^ICMJE

02-011

Has Data Monitoring Committee

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

Information Provided By

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

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