Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Beth Israel Deaconess Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165230

Purpose

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

Condition	Intervention	Phase
Neuroendocrine Tumor	Drug: Thalidomide Drug: Temodar	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Thalidomide Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	32
Study Start Date:	May 2002
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165230

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Matthew H. Kulke, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Study ID Numbers:	02-011
Study First Received:	September 9, 2005
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00165230 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

thalidomide
temodar
metastatic neuroendocrine tumor
unresectable neuroendocrine tumor

Study placed in the following topic categories:

Anti-Bacterial Agents
Neuroectodermal Tumors
Immunologic Factors
Thalidomide
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Antineoplastic Agents, Alkylating
Alkylating Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Temozolomide
Neuroendocrine Tumors

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Angiogenesis Inhibitors
Temozolomide
Immunosuppressive Agents

Pharmacologic Actions
Neuroendocrine Tumors
Anti-Bacterial Agents
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on May 06, 2009