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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

Thank you

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 CenterNew York, New York  10021