Neuroendocrine TumorPhase 2NCT00165230
Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
A Phase 2 study testing Thalidomide and Temodar in people with Neuroendocrine Tumor, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor
- What is being tested?
- Thalidomide and Temodar
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2002to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Frequent vomiting or medical condition that could interfere with oral medication intake
- Known HIV positivity or AIDS-related illness
- Pregnant or nursing women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.
Read the 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.
- Conditions
- Neuroendocrine Tumor
- Being tested
- Thalidomide, Temodar
- Keywords
- thalidomide, temodar, metastatic neuroendocrine tumor, unresectable neuroendocrine tumor
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
TemodarDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Investigators
- Matthew H. Kulke, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165230
- Sponsor's protocol ID
- 02-011
- Status last verified
- Apr 2009
- First submitted
- 9 Sep 2005
- Last updated
- 28 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00165230
- Acronym / sponsor ID
- 02-011
- Conditions
- Neuroendocrine Tumor
- Keywords
- thalidomide, temodar, metastatic neuroendocrine tumor, unresectable neuroendocrine tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- May 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide | Drug | – |
| Temodar | Drug | – |
Primary outcome
To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
2 secondary outcomes
To evaluate overall response and progression free survival of this patient population
to evaluate the safety of temodar and thalidomide.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew H. Kulke, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide and Temodar in people with Neuroendocrine Tumor, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2009; AzTrials last refreshed its copy on 7 Nov 2026.