Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

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

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.

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.

Eligibility: 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

Relevance to patient case: not relevant