Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

NCT00027638 | Completed Phase 2

• 3 other identifiers: MSKCC-01027CDR0000069051NCI-G01-2029
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Interventions

thalidomide DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Adenoma, Islet Cell; Lung Neoplasms; Neoplasms; Gastrinoma; Insulinoma; Carcinoma, Islet Cell; Vipoma; Somatostatinoma; Glucagonoma

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Leonard B. Saltz, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)