Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
Breast Cancer, Colorectal Cancer, Lung Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring male breast cancer, recurrent breast cancer, stage IV breast cancer, recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, recurrent pancreatic cancer, extensive stage small cell lung cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage IV non-small cell lung cancer, unspecified adult solid tumor, protocol specific, stage IV pancreatic cancer
Eligibility Criteria
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)
Sites / Locations
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Duke Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Denileukin Diftitox plus vaccine
This is a single arm Phase I safety study.