Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

April 27, 2009 updated by: Dana-Farber Cancer Institute

A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors

The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.

Study Overview

Status

Completed

Conditions

Neuroendocrine Tumor

Intervention / Treatment

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

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconness Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator: Matthew H. Kulke, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

April 28, 2009

Last Update Submitted That Met QC Criteria

April 27, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

02-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.