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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Neoplasm Metastasis

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence free survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Mitchell C. Posner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069324

NCT ID:

NCT00033748

Start Date:

December 2001

Completion Date:

June 2010

Related Keywords:

  • Colorectal Cancer
  • Neoplasm Metastasis
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • liver metastases
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Martha Jefferson HospitalCharlottesville, Virginia  22901
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mount Sinai Medical CenterNew York, New York  10029
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
NorthEast Oncology Associates - ConcordConcord, North Carolina  28025
Arthur G. James Cancer Hospital at Ohio State UniversityColumbus, Ohio  43210-1240
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
University Hospital at State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Memorial Regional Cancer Center at Memorial Regional HospitalHollywood, Florida  33021
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Siteman Cancer CenterSaint Louis, Missouri  63110