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)