Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Mitchell C. Posner

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00033748
Information obtained from ClinicalTrials.gov on December 14, 2011

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