Thalidomide in Combination With Temodar in Patients With... | NCT00165230

Studies
Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

NCT00165230

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Apr 28, 2009Estimated

Enrollment

Phase

Phase 2

Conditions

Neuroendocrine Tumor

Interventions

Thalidomide
Temodar

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2009

Last Update Posted Date

Apr 28, 2009Estimated

Name	Class
Brigham and Women's Hospital	OTHER
Massachusetts General Hospital	OTHER
Beth Israel Deaconess Medical Center	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew H. Kulke, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Dana-Farber Cancer Institute

Condition Browse Module

MeSH Terms

ID	Term
D018358	Neuroendocrine Tumors

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013792	Thalidomide
D000077204	Temozolomide

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Thalidomide	Drug
Temodar	Drug