Clinical trial NCT00027638: Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
Official title: Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Leonard B. Saltz, MD
role: STUDY_CHAIR
References: