Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

Neuroendocrine Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165230
• Other study ID #: 02-011
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: April 27, 2009
• Start date: May 2002
• Est. completion date: July 2006

Study information

• Verified date: April 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• Thalidomide

• Temodar

Locations

Country	Name	City	State
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Secondary	To evaluate overall response and progression free survival of this patient population
Secondary	to evaluate the safety of temodar and thalidomide.