Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Neuroendocrine Tumor

Thank you

Trial Information

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

- 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

- 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.

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

- Known HIV positivity or AIDS-related illness

- Pregnant or nursing women

Type of Study:


Study Design:

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

Outcome Measure:

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

Principal Investigator

Matthew H. Kulke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2002

Completion Date:

July 2006

Related Keywords:

  • Neuroendocrine Tumor
  • thalidomide
  • temodar
  • metastatic neuroendocrine tumor
  • unresectable neuroendocrine tumor
  • Neuroendocrine Tumors



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Beth Israel Deaconness Medical Center Boston, Massachusetts  02215