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Biological Therapy in Treating Patients With Metastatic Cancer
This study is ongoing, but not recruiting participants.
First Received: May 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004604
  Purpose

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
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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Gallbladder Cancer Head and Neck Cancer Liver Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Stomach Cancer
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 18
Study Start Date: February 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004604

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Herbert K. Lyerly, MD Duke University
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009