Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

NCT ID: NCT00027638

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2003-12-31

Brief 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.

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.

Conditions

Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Lung Cancer; Neoplastic Syndrome

Study Design

• Primary Study Purpose: TREATMENT

Interventions

thalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Leonard B. Saltz, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000069051

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G01-2029

Identifier Type: -

Identifier Source: secondary_id

MSKCC-01027

Identifier Type: -

Identifier Source: org_study_id