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


Phase 2
N/A
N/A
Not Enrolling
Both
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Neoplastic Syndrome

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MSKCC-01027

NCT ID:

NCT00027638

Start Date:

March 2001

Completion Date:

December 2003

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Lung Cancer
  • Neoplastic Syndrome
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • gastrinoma
  • insulinoma
  • recurrent islet cell carcinoma
  • WDHA syndrome
  • somatostatinoma
  • pancreatic polypeptide tumor
  • glucagonoma
  • pulmonary carcinoid tumor
  • Neoplasms
  • Carcinoid Tumor
  • Lung Neoplasms
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Adenoma, Islet Cell

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021