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Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033748
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Biological: monoclonal antibody 11D10 anti-idiotype Biological: monoclonal antibody 3H1 Alu Gel Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the 2-year recurrence-free survival of patients with minimal metastatic colorectal cancer after hepatic resection when treated with adjuvant monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine.

Secondary

  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Beginning 6-12 weeks after curative hepatic resection, patients receive monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine intracutaneously at separate sites on days 1, 15, 29, and 45, then subcutaneously monthly for 4 months.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 9 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer
Study Start Date : December 2001
Actual Primary Completion Date : March 2007
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined Monoclonal Antibody Therapy
Patients with minimal metastatic colorectal cancer are treated with 2 anti-idiotype monoclonal antibodies
Biological: monoclonal antibody 11D10 anti-idiotype
2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
Other Name: TriAb

Biological: monoclonal antibody 3H1 Alu Gel
2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
Other Name: CeaVac




Primary Outcome Measures :
  1. Recurrence free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 5 years ]


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

DISEASE CHARACTERISTICS:

  • Histologically confirmed hepatic colorectal metastases
  • Must have undergone complete resection of hepatic colorectal metastases with tumor-free margins (curative resection) at least 6, but no more than 10, weeks prior to study entry
  • No evaluable or measurable disease after hepatic resection, documented by intraoperative palpation or imaging studies including intraoperative ultrasound, CT scan, or MRI
  • No hereditary non-polyposis colon cancer type B
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 mg/dL
  • AST no greater than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Gastrointestinal:

  • No celiac disease
  • No familial polyposis
  • No Gardner's syndrome
  • No Peutz-Jeghers syndrome

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No seizure disorders requiring continuous medication
  • No history of clinically significant hypersensitivity reactions, including known hypersensitivity to rodent proteins
  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior murine antibodies (e.g., oncoscint scan)
  • No prior monoclonal antibody 3H1 anti-idiotype vaccine or monoclonal antibody 11D10 anti-idiotype vaccine

Chemotherapy:

  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • Prior treatment for primary lesion or hepatic metastases allowed
  • No concurrent immunomodulatory therapy

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): NCT00033748


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Locations
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United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
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
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
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
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
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
University of Massachusetts Memorial Medical 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
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
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
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
University Hospital at State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805
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 - Durham
Durham, North Carolina, United States, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Cape Fear Valley Health System
Fayetteville, North Carolina, United States, 28302-2000
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States, 28503-1678
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Arthur G. James Cancer Hospital 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 Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75219
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
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States, 24014
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Mitchell C. Posner, MD University of Chicago

Publications of Results:
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00033748     History of Changes
Other Study ID Numbers: CALGB-89903
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-89903
CDR0000069324 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
liver metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents