Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-89903 NCT00033748

Objectives

Primary

1. 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

1. Determine the toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• CTC 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm³
• Platelet count at least 150,000/mm³

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

Expected Enrollment

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

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.

Posner MC, Niedzwiecki D, Venook AP, et al.: 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 15 (1): 158-64, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Mitchell Posner, MD, Protocol chair		Ph: 773-834-0156; 888-824-0200

Registry Information
Official Title		Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients with Minimal Metastatic Colorectal Cancer
Trial Start Date		2001-12-31
Trial Completion Date		2009-08-11
Registered in ClinicalTrials.gov		NCT00033748
Date Submitted to PDQ		2002-03-06
Information Last Verified		2004-07-22
NCI Grant/Contract Number		CA31946

Back to Top