Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Lung Cancer Neoplastic Syndrome |
Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers) |
| Study Start Date: | March 2001 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00027638 History of Changes |
| Other Study ID Numbers: | MSKCC-01027, CDR0000069051, NCI-G01-2029 |
| Study First Received: | December 7, 2001 |
| Last Updated: | June 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor gastrinoma insulinoma recurrent islet cell carcinoma |
WDHA syndrome somatostatinoma pancreatic polypeptide tumor glucagonoma pulmonary carcinoid tumor |
Additional relevant MeSH terms:
|
Neoplasms Carcinoid Tumor Lung Neoplasms Neuroendocrine Tumors Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Adenoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Adenoma Pancreatic Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Thalidomide Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013