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Trial record 19 of 2826 for:    Neuroendocrine Neoplasm | Neuroendocrine Tumors

Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT00165230
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2009
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Drug: Thalidomide Drug: Temodar Phase 2

Detailed Description:
  • Patients will receive thalidomide orally once daily continuously unless they experience significant side effects. Temodar is given orally once a day for one week, followed by a one week break period. This one week on/one week off schedule will continue for the duration of treatment unless there are significant side effects.
  • After eight weeks (2 cycles) a CT scan will be performed to see how the treatment has affected the patient's tumor. Patients will continue taking the study drug unless there is evidence of tumor growth.
  • Regular blood tests will be done weekly during the first two months to make sure that the treatment is not resulting in serious side effects. If there are no side effects during the first two months, the blood tests may decrease in frequency to every two weeks.
  • Immediately after the patient has completed the study they will be evaluated by physical exam, blood work, and a CT scan. The follow-up will consist of clinic visits and phone calls every 3 months.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
Study Start Date : May 2002
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.

Secondary Outcome Measures :
  1. To evaluate overall response and progression free survival of this patient population
  2. to evaluate the safety of temodar and thalidomide.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
  • Prior treatment with chemoembolization or cryotherapy is allowed
  • Radiotherapy is allowed if completed more than 4 weeks prior to study.
  • Measurable disease as defined by RECIST criteria
  • Age greater than or equal to 18 years.
  • ECOG performance status of less than or equal to 2
  • ANC >1,500/mm3
  • Platelet Count > 100,000/mm3
  • Hemoglobin > 9 g/dl
  • Serum creatinine < 1.5 x ULN
  • Total bilirubin < 2 x ULN
  • SGOT and SGPT < 2 x ULN
  • Alkaline phosphatase < 2 x ULN
  • Life expectancy of greater than 12 weeks

Exclusion Criteria:

  • Clinically symptomatic central nervous system metastases or carcinomatous meningitis
  • Myocardial infarction in past 6 months
  • Major surgery in past two weeks
  • Uncontrolled serious medical or psychiatric illness
  • Insufficient recovery from all active toxicities of prior therapies
  • Active nonmalignant systemic disease
  • Frequent vomiting or medical condition that could interfere with oral medication intake
  • Known HIV positivity or AIDS-related illness
  • Pregnant or nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165230


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Matthew H. Kulke, MD Dana-Farber Cancer Institute

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ClinicalTrials.gov Identifier: NCT00165230     History of Changes
Other Study ID Numbers: 02-011
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009
Keywords provided by Dana-Farber Cancer Institute:
thalidomide
temodar
metastatic neuroendocrine tumor
unresectable neuroendocrine tumor
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Thalidomide
Temozolomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action