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)