Carcinoid Tumor, Childhood |
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Clinical Trial: Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
This study is no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| gastrointestinal carcinoid tumor Islet Cell Carcinoma pulmonary carcinoid tumor | Drug: thalidomide Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: growth factor antagonist therapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Carcinoid Tumors; Digestive Diseases; Endocrine Diseases; Lung Cancer; Pancreatic Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Thalidomide in Patients With Metastatic Low-Grade Neuroendocrine Tumors
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
Criteria
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
Location Information
Leonard Bruce Saltz, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: December 2003
Last Updated: October 13, 2004
Record first received: December 7, 2001
ClinicalTrials.gov Identifier: NCT00027638
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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