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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004604 |
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment.
Condition | Intervention | Phase |
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Breast Cancer Colorectal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Head and Neck Cancer Liver Cancer Lung Cancer Metastatic Cancer Ovarian Cancer Pancreatic Cancer Testicular Germ Cell Tumor |
Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Human Cultured Dendritic Cells in Patients With Metastatic Malignancies Expressing Carcinoembryonic Antigen |
Estimated Enrollment: | 18 |
Study Start Date: | February 1997 |
OBJECTIVES: I. Determine the safety and dose limiting toxicity of an intravenous vaccine of autologous, cultured, dendritic cells pulsed with carcinoembryonic antigen (CEA) RNA in patients with metastatic adenocarcinoma expressing CEA. II. Assess the cellular immune response to the CEA protein.
III. Assess the clinical and biochemical response to the treatment and the duration of such response.
OUTLINE: This a three tiered, open label, uncontrolled, dose escalation study. The first 3 patients receive a low dose of intravenous carcinoembryonic antigen (CEA) RNA-pulsed autologous dendritic cells (DC) at weeks 0, 1, 2, and 3. Patients are evaluated for dose limiting toxicity (DLT), immune response, and the antitumor response for at least 1 week before dose escalation may proceed. If there is no DLT in the first three, the next 3 patients are treated at a medium dose of CEA RNA-pulsed autologous DC at 0, 1, 2, and 3 weeks. Finally, if DLT is not seen at the medium dose, the final 6 patients receive intravenous infusions of a high dose of CEA RNA-pulsed autologous DC at weeks 0, 1, 2, and 3. If 1-2 patient(s) experience DLT at the either the low or medium dose levels, 3 more patients are entered at the same dose. If no further DLT occurs, then dose escalation continues. As soon as 3 toxic events occur in 3-6 patients at one dose level, accrual at that level ceases. The MTD is defined as the dose level immediately below that at which more than 3 of 6 patients develop DLT.
PROJECTED ACCRUAL: A minimum of 3 and a maximum of 18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma expressing carcinoembryonic antigen (CEA) that has failed conventional therapy Measurable or evaluable disease May include elevated CEA level No previously irradiated or known new CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: WBC at least 3,000/mm3 Absolute lymphocyte count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 PT less than 1.25 times normal limit PTT less that 1.66 times normal limit Fibrinogen greater than 0.75 times normal limit Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No NYHA class III or IV Pulmonary: FEV1 greater than 70% of predicted FVC greater than 70% of predicted DLCO greater than 70% of predicted No asthma or chronic obstructive pulmonary disease Other: No active or chronic infection (including urinary tract infection) No viral hepatitis HIV negative No concurrent second malignancy other than nonmelanoma skin cancer or controlled superficial bladder cancer No hepatic disease No history of other autoimmune disease such as inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis
PRIOR CONCURRENT THERAPY: Must have recovered from all acute toxic effects Biologic therapy: No concurrent biologic therapy At least 6 weeks since biologic therapy No concurrent immunotherapy No more than 1 prior biologic regimen Chemotherapy: No concurrent chemotherapy At least 6 weeks since chemotherapy No more than 1 prior chemotherapy regimen Endocrine therapy: At least 6 weeks since steroid therapy Radiotherapy: No concurrent radiotherapy At least 12 weeks since therapy including Sr 89 At least 6 weeks since other radiotherapy No prior cranial radiotherapy Surgery: Not specified Other: No concurrent immunosuppressives such as azathioprine or cyclosporine
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Herbert K. Lyerly, MD | Duke University |
Study ID Numbers: | CDR0000065619, DUMC-96098, DUMC-1817-99-10R3, NCI-G97-1272 |
Study First Received: | May 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004604 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV breast cancer recurrent breast cancer stage IV gastric cancer recurrent gastric cancer recurrent non-small cell lung cancer recurrent pancreatic cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer inflammatory breast cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer extensive stage small cell lung cancer recurrent small cell lung cancer |
unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor thyroid gland medullary carcinoma stage IV non-small cell lung cancer stage IV salivary gland cancer recurrent salivary gland cancer Paget disease of the breast with invasive ductal carcinoma adult primary hepatocellular carcinoma testicular yolk sac tumor lung metastases liver metastases |
Gallbladder Diseases Thoracic Neoplasms Liver Diseases Rectal Neoplasms Carcinoma, Hepatocellular Pancreatic Neoplasms Thyroid Cancer, Medullary Colonic Diseases Urogenital Neoplasms Breast Cancer, Male Rectal Diseases Lung Neoplasms Neoplasm Metastasis Ovarian Cancer Paget Disease |
Salivary Gland Diseases Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Testicular Cancer Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Testicular Neoplasms Carcinoma Carcinoma, Small Cell Breast Neoplasms, Male Bile Duct Diseases Lung Diseases Pancreatic Diseases |
Thoracic Neoplasms Gallbladder Diseases Liver Diseases Gonadal Disorders Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Ovarian Diseases Rectal Diseases Genital Diseases, Female Liver Neoplasms Neoplastic Processes Pathologic Processes Stomach Diseases |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Biliary Tract Diseases Neoplasms, Germ Cell and Embryonal Stomach Neoplasms Neoplasm Metastasis Breast Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Biliary Tract Neoplasms Skin Diseases |