Biological Therapy in Treating Patients With Metastatic Cancer

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CEA RNA-pulsed DC cancer vaccine

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CEA RNA-pulsed DC cancer vaccine

Arm Description

carcinoembryonic antigen RNA-pulsed dendritic cells

Outcomes

Primary Outcome Measures

Safety

To determine the safety and dose limiting toxicity of intravenous injections of autologous, cultured, dendritic cells pulsed with CEA RNA.

Secondary Outcome Measures

Immune response

Evaluation of cellular immune response to the CEA protein. Evaluation of clinical and biochemical response to the treatment and the duration of such response

Full Information

NCT ID

NCT00004604

First Posted

May 2, 2000

Last Updated

February 21, 2013

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00004604

Brief Title

Biological Therapy in Treating Patients With Metastatic Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

February 1997 (undefined)

Primary Completion Date

June 2001 (Actual)

Study Completion Date

July 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CEA RNA-pulsed DC cancer vaccine

Arm Type

Experimental

Arm Description

carcinoembryonic antigen RNA-pulsed dendritic cells

Intervention Type

Biological

Intervention Name(s)

CEA RNA-pulsed DC cancer vaccine

Intervention Description

carcinoembryonic antigen RNA-pulsed dendritic cells

Primary Outcome Measure Information:

Title

Safety

Description

To determine the safety and dose limiting toxicity of intravenous injections of autologous, cultured, dendritic cells pulsed with CEA RNA.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Immune response

Description

Evaluation of cellular immune response to the CEA protein. Evaluation of clinical and biochemical response to the treatment and the duration of such response

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Herbert K. Lyerly, MD

Organizational Affiliation

Duke Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Duke Comprehensive Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Breast Cancer, Colorectal Cancer, Extrahepatic Bile Duct Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial