Gastrointestinal Carcinoid TumorPhase 2NCT00027638
Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
A Phase 2 study testing thalidomide in people with Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have metastatic neuroendocrine tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer
- What is being tested?
- thalidomide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Dec 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed low-grade neuroendocrine tumors
- Carcinoid tumors
- Islet cell tumors
- Metastatic disease
- Progression of disease within past 4 weeks by radiological evidence
- At least 1 bidimensionally measurable lesion by CT scan or MRI
- Bone metastasis not considered measurable if only site of disease
- No active brain metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- AST no greater than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 50 mL/min
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study
- No grade 2 or greater neuropathy
- No other clinical circumstances that would preclude study
- No other prior malignancy except:
- Non-melanoma skin cancer
- Other cancer that has been curatively treated, has had no evidence of recurrence within the past 5 years, and is at low risk for recurrence
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior thalidomide
- No concurrent interferon
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- At least 4 weeks since prior major surgery
Other:
- No more than 1 prior systemic therapy regimen
- At least 4 weeks since prior systemic therapy regimen
- No other concurrent therapeutic agent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)
RATIONALE: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have metastatic neuroendocrine tumors.
Read the detailed description
OBJECTIVES:
- Determine the safety and efficacy of thalidomide in patients with metastatic low-grade neuroendocrine tumors.
OUTLINE: Patients receive oral thalidomide once daily on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
- Being tested
- thalidomide
- Keywords
- metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, gastrinoma, insulinoma, recurrent islet cell carcinoma, WDHA syndrome, somatostatinoma, pancreatic polypeptide tumor, glucagonoma, pulmonary carcinoid tumor
- Medical subject headings
- Adenoma, Islet Cell, Lung Neoplasms, Neoplasms, Gastrinoma, Insulinoma, Carcinoma, Islet Cell, Vipoma, Somatostatinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Carcinoid TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Leonard B. Saltz, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027638
- Sponsor's protocol ID
- MSKCC-01027
- Other IDs
- CDR0000069051, NCI-G01-2029
- Status last verified
- Jun 2013
- First submitted
- 7 Dec 2001
- Last updated
- 18 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)
- ClinicalTrials.gov ID
- NCT00027638
- Acronym / sponsor ID
- MSKCC-01027
- Keywords
- metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, gastrinoma, insulinoma, recurrent islet cell carcinoma, WDHA syndrome, somatostatinoma, pancreatic polypeptide tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have metastatic neuroendocrine tumors.
Detailed description
OBJECTIVES:
- Determine the safety and efficacy of thalidomide in patients with metastatic low-grade neuroendocrine tumors.
OUTLINE: Patients receive oral thalidomide once daily on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | – |
Primary outcome
Not reported in the source record.
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 18 Jun 2013.
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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.
Leonard B. Saltz, MD study chair
Memorial Sloan Kettering Cancer Center
1 site 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 in people with Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 18 Jun 2013.