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

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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.


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


  Show 75 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Mitchell C. Posner, MD University of Chicago

Publications of Results:
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:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs