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Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00027638
Enrollment
Unknown
Registered
2003-01-27
Start date
2001-03-31
Completion date
2003-12-31
Last updated
2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGthalidomide

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026