Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
1 other identifier
interventional
32
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2002
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedApril 28, 2009
April 1, 2009
4.2 years
September 9, 2005
April 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Secondary Outcomes (2)
To evaluate overall response and progression free survival of this patient population
to evaluate the safety of temodar and thalidomide.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew H. Kulke, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
May 1, 2002
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
April 28, 2009
Record last verified: 2009-04