Clinical trial NCT00165230: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumor
Keywords: thalidomide
temodar
metastatic neuroendocrine tumor
unresectable neuroendocrine tumor
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2005-09-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Secondary outcomes:
measure: To evaluate overall response and progression free survival of this patient population
measure: to evaluate the safety of temodar and thalidomide.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew H. Kulke, MD
role: PRINCIPAL_INVESTIGATOR
References: