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Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
This study has been completed.
First Received: November 4, 2003   Last Updated: August 29, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072163
  Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma.


Condition Intervention Phase
Melanoma (Skin)
Metastatic Cancer
Drug: temozolomide
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2003
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide.

Secondary

  • Determine the toxic effects of and tolerance to this regimen in these patients.
  • Determine the objective response rate in extracranial metastases of patients treated with this regimen.
  • Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 2 years.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 1.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic melanoma
  • Clinical evidence of brain metastases

    • At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI

      • The following lesions are not considered measurable:

        • Bone lesions
        • Leptomeningeal disease
        • Ascites
        • Pleural/pericardial effusion
        • Lymphangitis cutis/pulmonis
        • Abdominal masses that are not confirmed and followed by imaging techniques
        • Cystic lesions
        • Lesions situated in a previously irradiated area, unless new growth is documented

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • CTC 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Lactic dehydrogenase no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 2 mg/dL

Cardiovascular

  • No history of active angina
  • No history of significant ventricular arrhythmia
  • No history of deep vein thrombosis
  • No myocardial infarction within the past 6 months
  • No acute abnormality by EKG
  • No uncontrolled arrhythmia

Pulmonary

  • No history of pulmonary embolism

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 1 highly-effective and 1 additional method of contraception for 28 days before, during, and for 4 weeks after study participation
  • No known HIV disease
  • Thyroid-stimulating hormone normal
  • Serum anticonvulsant levels normal (for patients on anticonvulsants)
  • No frequent vomiting and/or any other medical condition (e.g., partial bowel obstruction) that would preclude oral medication intake
  • No preexisting neuropathy greater than grade 1
  • No uncontrolled seizures
  • No other concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior cytokines

    • Biologic agents used as adjuvants, vaccines, and cellular therapies do not require a 4-week washout period
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • No more than 1 prior chemotherapy regimen
  • No prior chemotherapy for brain metastases
  • No prior continuous daily temozolomide
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except steroids and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) or for control of intracranial edema from brain metastases

Radiotherapy

  • See Disease Characteristics
  • Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease in a measurable CNS lesion
  • Prior stereotactic radiotherapy allowed provided patient has progressive disease in a measurable CNS lesion
  • At least 4 weeks since prior WBRT
  • At least 3 weeks since prior stereotactic radiosurgery
  • No concurrent radiotherapy

Surgery

  • At least 3 weeks since prior surgical resection

Other

  • No concurrent warfarin or heparin products or their derivatives
  • No concurrent antiplatelet therapy (e.g., daily aspirin, ibuprofen, or clopidogrel bisulfate)
  • No concurrent bisphosphonates (e.g., zoledronate)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072163

  Hide Study Locations
Locations
United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, California
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Palm Beach Cancer Institute - West Palm Beach
West Palm Beach, Florida, United States, 33401
United States, Illinois
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
La Grange Oncology Associates
La Grange, Illinois, United States, 60525
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
North Shore University Hospital
Manhasset, New York, United States, 11030
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States, 28302-2000
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States, 28025
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22902
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States, 24014
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Susan E. Krown, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000335518, CALGB-500102
Study First Received: November 4, 2003
Last Updated: August 29, 2009
ClinicalTrials.gov Identifier: NCT00072163     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
tumors metastatic to brain
recurrent melanoma

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Anti-Bacterial Agents
Neoplastic Processes
Pathologic Processes
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Neoplasm Metastasis
Nevi and Melanomas
Angiogenesis Modulating Agents
Growth Inhibitors
Alkylating Agents
Neoplasms by Histologic Type
Growth Substances
Temozolomide
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Antineoplastic Agents, Alkylating
Leprostatic Agents

ClinicalTrials.gov processed this record on November 27, 2009