Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer

DISEASE CHARACTERISTICS:

* Histologically confirmed malignancy

  * Metastatic disease
* Tumor expresses carcinoembryonic antigen (CEA), as evidenced by any of the following:

  * At least 50% of tumor expresses CEA by immunohistochemistry (IHC) with ≥ a moderate intensity of staining
  * Peripheral blood CEA level \> 5.0 ng/mL
  * Tumor known to be universally CEA-positive (e.g., colon or rectal cancer)
* Measurable or evaluable disease
* Received or refused prior therapy with a possible survival or palliative benefit AND meets the following disease-specific criteria:

  * Patients with colorectal cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:

    * Fluorouracil or capecitabine AND oxaliplatin
    * Fluorouracil or capecitabine AND irinotecan
    * Chemotherapy in combination with bevacizumab
  * Patients with breast cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:

    * Anthracycline- or taxane-based chemotherapy
    * Chemotherapy AND trastuzumab (Herceptin®) (required for patients with tumors overexpressing HER2/neu (i.e., 3+ by IHC or positive by fluorescence in situ hybridization \[FISH\])
  * Patients with lung cancer must have experienced disease progression during ≥ 1 prior palliative chemotherapy regimen for metastatic disease comprising 1 of the following regimens:

    * Platinum-based (e.g., cisplatin or carboplatin) chemotherapy (for chemotherapy-naive patients only)
    * Taxane-based (e.g., docetaxel or paclitaxel) chemotherapy OR vinorelbine (for patients who received prior chemotherapy)
  * Patients with pancreatic cancer must have experienced disease progression during prior chemotherapy, including gemcitabine
  * Patients with other malignancies must have experienced disease progression after prior first-line therapy that would confer a survival or palliative benefit, if such a therapy exists

    * Patients who experienced disease progression during prior first-line palliative chemotherapy must be advised regarding second-line therapy before study enrollment
* Previously resected brain metastases allowed provided there is no evidence of brain metastasis within the past month by MRI or CT scan
* No requirement for further systemic chemotherapy for ≥ 3 months
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 18 and over

Sex

* Male or female

Menopausal status

* Not specified

Performance status

* Karnofsky 70-100%

Life expectancy

* More than 6 months

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin \< 1.5 mg/dL (≤ 2.0 mg/dL for patients with Gilbert's syndrome)
* SGOT and SGPT \< 1.5 times upper limit of normal
* Albumin ≥ 3.0 g/dL
* No active acute or chronic viral hepatitis

  * Hepatitis B surface antigen negative
  * Hepatitis C negative
* No other hepatic disease that would preclude study treatment

Renal

* Creatinine \< 1.5 mg/dL
* No active acute or chronic urinary tract infection

Cardiovascular

* No New York Heart Association class III-IV cardiac disease

Immunologic

* HIV negative
* No history of autoimmune disease\*, including, but not limited to, the following:

  * Inflammatory bowel disease
  * Systemic lupus erythematosus
  * Ankylosing spondylitis
  * Scleroderma
  * Multiple sclerosis
* No active cytomegalovirus (CMV) disease

  * Patients with CMV-seropositivity are eligible
* No other active acute or chronic infection
* No history of allergies to eggs or any component of the study vaccine, denileukin diftitox, or diphtheria toxin NOTE: \*Patients with a positive anti-nuclear antibody (ANA) ≤ 1:256 with no other evidence of autoimmune disease are eligible

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after completion of study treatment
* No acute or chronic skin disorder that would preclude study treatment
* No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
* No psychological or medical impediment that would preclude study compliance
* No other serious acute or chronic illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* Prior vaccine, dendritic cell, or CEA-targeted immunotherapy allowed
* At least 4 weeks since prior and no other concurrent immunotherapy
* Concurrent palliative single-agent trastuzumab for breast cancer allowed provided patient has been on therapy for ≥ 3 months before study entry

Chemotherapy

* See Disease Characteristics
* At least 4 weeks since prior and no concurrent chemotherapy

Endocrine therapy

* At least 4 weeks since prior hormonal therapy
* At least 6 weeks since prior steroid therapy except steroids used as premedication for chemotherapy or contrast-enhanced studies
* No concurrent steroids, including corticosteroids administered to manage toxic effects from dendritic cell or denileukin diftitox administration
* Concurrent palliative endocrine therapy for breast cancer allowed provided patient has been on therapy for ≥ 3 months before study entry

Radiotherapy

* At least 4 weeks since prior and no concurrent radiotherapy

Surgery

* See Disease Characteristics

Other

* Recovered from all prior therapy
* At least 4 weeks since prior investigational drugs or procedures
* At least 4 weeks since other prior therapy
* No other concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine)