Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Intervention: falimarev; inalimarev; sargramostim; therapeutic autologous dendritic cells
Intervention description: Given subcutaneously and intradermally; Given subcutaneously and intradermally; Given subcutaneously; Given subcutaneously and intradermally
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: liver metastases; adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer; adenocarcinoma of the rectum; recurrent rectal cancer; stage IV rectal cancer; lung metastases

Summary:

      RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make
      the body build an effective immune response to kill tumor cells. Biological therapies, such
      as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system
      in different ways and stop tumor cells from growing. Combining different types of biological
      therapies may kill more tumor cells.

      PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with
      dendritic cells to see how well it works compared to giving vaccine therapy together with
      GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by
      surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma
             of the colon and rectum

          -  Must have undergone complete resection of hepatic or pulmonary metastases with
             curative intent

               -  No evidence of gross residual disease after surgery

               -  One or more resected and ablated lesions allowed provided all gross residual
                  tumor was destroyed by ablation

               -  Repeated resections of hepatic metastatic disease or resections of extrahepatic
                  metastases prior to resection of the hepatic metastases allowed provided the most
                  recent hepatic metastatic resection included total disease resection and/or
                  ablation

          -  Must have received at least 2 months of perioperative systemic chemotherapy (including
             preoperative and/or postoperative chemotherapy) that was completed at least 1 month
             ago

        PATIENT CHARACTERISTICS:

        Age

          -  At least 18

        Performance status

          -  Karnofsky 70-100%

        Life expectancy

          -  At least 6 months

        Hematopoietic

          -  Platelet count ≥ 75,000/mm^3

          -  Hemoglobin ≥ 8.5 g/dL (transfusion or epoetin alfa allowed)

        Hepatic

          -  Bilirubin ≤ 2.0 mg/dL

          -  Hepatitis B surface antigen negative

          -  Hepatitis C antibody negative

          -  No other serious chronic or acute hepatic disease

        Renal

          -  Creatinine ≤ 1.5 mg/dL OR

          -  Creatinine clearance > 60 mL/min

        Cardiovascular

          -  No New York Heart Association class III or IV cardiac disease

          -  No other serious chronic or acute cardiac disease

        Pulmonary

          -  No asthma

          -  No chronic obstructive pulmonary disease

          -  No other serious chronic or acute pulmonary disease

        Immunologic

          -  No history of autoimmune disease, including, but not limited to, any of the following:

               -  Inflammatory bowel disease

               -  Systemic lupus erythematosus

               -  Ankylosing spondylitis

               -  Scleroderma

               -  Multiple sclerosis

          -  No human immunodeficiency virus (HIV) infection by enzyme-linked immunosorbent assay
             (ELISA) and western blot

          -  Not immunocompromised (by disease or therapy)

          -  No allergy to eggs or any component of the study vaccine

          -  No history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination

          -  No allergy or untoward reaction to sargramostim (GM-CSF)

          -  No active acute or chronic infection, including urinary tract infection within the
             past 72 hours

          -  No inflammatory bowel conditions, including, but not limited to, the following:

               -  Active infectious enteritis

               -  Eosinophilic enteritis

          -  No acute, chronic, or exfoliative skin disorders, including any of the following:

               -  Extensive psoriasis

               -  Burns

               -  Impetigo

               -  Disseminated zoster

               -  Varicella zoster

               -  Severe acne

               -  Other open rashes or wounds

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Able to avoid close contact or household contact for 3 weeks after each vaccination
             with the following individuals:

               -  Children under 5 years of age

               -  Pregnant or nursing women

               -  Individuals with prior or concurrent extensive eczema, other eczematoid skin
                  disorders, or other acute or chronic skin conditions

               -  Immunosuppressed or immunodeficient individuals

          -  No medical or psychological condition that would preclude study compliance

          -  No extensive eczema

          -  No other serious chronic or acute illness that would preclude study participation

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled
             superficial bladder cancer, or previously treated carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No other concurrent immunotherapy

        Chemotherapy

          -  See Disease Characteristics

          -  No concurrent chemotherapy

        Endocrine therapy

          -  More than 6 weeks since prior and no concurrent steroid therapy

        Radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  No other concurrent immunosuppressants (e.g., azathioprine or cyclosporine)