Clinical trial · Interventional

Biological Therapy in Treating Patients With Metastatic Cancer

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

NCT00004604CI-TRIAL-00009547completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (12)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Extrahepatic Bile Duct Cancer	Malignant Extrahepatic Bile Duct Neoplasm	ALIAS	0.90
Gallbladder Cancer	Malignant Gallbladder Neoplasm	CURATED_EXACT	0.92
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Metastatic Cancer	Malignant Neoplasm	CURATED_BROADER

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
CEA RNA-pulsed DC cancer vaccine	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
CEA RNA-pulsed DC cancer vaccine
description
carcinoembryonic antigen RNA-pulsed dendritic cells
interventionNames
1. Biological: CEA RNA-pulsed DC cancer vaccine

Primary outcomes (1)

measure
Safety
timeFrame
12 months
description
To determine the safety and dose limiting toxicity of intravenous injections of autologous, cultured, dendritic cells pulsed with CEA RNA.

Secondary outcomes (1)

measure
Immune response
timeFrame
12 weeks
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Feb 1, 1997
Primary completion: Jun 1, 2001
Completion: Jul 1, 2002
First posted: Apr 28, 2004
Last update posted: Feb 22, 2013
Enrollment: 24 (actual)
Lead sponsor: Duke University OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: 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, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, male breast cancer, stage IV pancreatic cancer