Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

Lung Cancer Clinical Trial

Official title:

Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027638
• Other study ID #: MSKCC-01027
• Secondary ID: CDR0000069051NCI
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2001
• Last updated: June 17, 2013
• Start date: March 2001
• Est. completion date: December 2003

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Islet Cell Tumor
• Lung Cancer
• Malignant Carcinoid Syndrome
• Neoplasms
• Neoplastic Syndrome
• Neuroendocrine Tumors

Intervention

Drug:
• thalidomide

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,