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Colorectal CancerPhase 2NCT00033748

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

A Phase 2 study testing monoclonal antibody 11D10 anti-idiotype and monoclonal antibody 3H1 Alu Gel in people with Colorectal Cancer and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 75 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Metastatic Cancer
What is being tested?
monoclonal antibody 11D10 anti-idiotype and monoclonal antibody 3H1 Alu Gel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
75 sitesUnited States
Study dates
Dec 2001to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

75 sites in 1 country.

75 sites in 1 country

United States75 sites

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36207

  • Veterans Affairs Medical Center - Asheville

    Asheville, North Carolina, 28805

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22902

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital at Ohio State University

    Columbus, Ohio, 43210-1240

  • NorthEast Oncology Associates - Concord

    Concord, North Carolina, 28025

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75219

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    East Syracuse, New York, 13057

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28302-2000

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana, 46885-5099

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • Memorial Regional Cancer Center at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Lenoir Memorial Hospital Cancer Center

    Kinston, North Carolina, 28503-1678

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Veterans Affairs Medical Center - Las Vegas

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • West Suburban Center for Cancer Care

    River Forest, Illinois, 60305

  • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke

    Roanoke, Virginia, 24014

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • University Hospital at State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Veterans Affairs Medical Center - Washington, DC

    Washington D.C., District of Columbia, 20422

  • Zimmer Cancer Center at New Hanover Regional Medical Center

    Wilmington, North Carolina, 28402-9025

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer

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.

Read the 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.

Being tested
monoclonal antibody 11D10 anti-idiotype, monoclonal antibody 3H1 Alu Gel
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • monoclonal antibody 11D10 anti-idiotypeBiological

    Also called TriAb

    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

  • monoclonal antibody 3H1 Alu GelBiological

    Also called CeaVac

    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

Study groups in NCT00033748
Study groupRoleWhat they receive
Combined Monoclonal Antibody TherapyExperimentalPatients with minimal metastatic colorectal cancer are treated with 2 anti-idiotype monoclonal antibodies
Receives: Biological: monoclonal antibody 11D10 anti-idiotype; Biological: monoclonal antibody 3H1 Alu Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence free survival

    Measured: 2 years

Secondary outcomes (1)

  1. Toxicity

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 2001
  3. Primary completionMar 2007
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033748
Sponsor's protocol ID
CALGB-89903
Other IDs
U10CA031946, CALGB-89903, CDR0000069324
Status last verified
Jul 2016
First submitted
9 Apr 2002
Last updated
19 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Posner MC, Niedzwiecki D, Venook AP, Hollis DR, Kindler HL, Martin EW, Schilsky RL, Goldberg RM, Mayer RJ. A phase II prospective multi-institutional trial of adjuvant active specific immunotherapy following curative resection of colorectal cancer hepatic metastases: cancer and leukemia group B study 89903. Ann Surg Oncol. 2008 Jan;15(1):158-64. doi: 10.1245/s10434-007-9654-7. Epub 2007 Nov 16.

    PubMed 18008108

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing monoclonal antibody 11D10 anti-idiotype and monoclonal antibody 3H1 Alu Gel in people with Colorectal Cancer and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 75 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033748, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.

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