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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Colorectal Cancer

Treatments: Biological: monoclonal antibody 11D10 anti-idiotype; Biological: monoclonal antibody 3H1 Alu Gel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00033748

U10CA031946 (U.S. NIH Grant/Contract)

CALGB-89903

CDR0000069324 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Combined Monoclonal Antibody Therapy

Experimental group

Description:

Patients with minimal metastatic colorectal cancer are treated with 2 anti-idiotype monoclonal antibodies

Treatment:

Biological: monoclonal antibody 3H1 Alu Gel

Biological: monoclonal antibody 11D10 anti-idiotype