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Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

Primary Purpose

Breast Cancer, Colorectal Cancer, Gallbladder Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TRICOM-CEA(6D)
Sponsored by
Michael Morse, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent gallbladder cancer, unresectable gallbladder cancer, thyroid gland medullary carcinoma, recurrent salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, Paget disease of the breast with intraductal carcinoma, Paget disease of the breast with invasive ductal carcinoma, adult primary hepatocellular carcinoma, diffuse adenocarcinoma of the stomach, intestinal adenocarcinoma of the stomach, mixed adenocarcinoma of the stomach, adenocarcinoma of the colon, adenocarcinoma of the gallbladder, adenocarcinoma of the rectum, recurrent malignant testicular germ cell tumor, stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, male breast cancer, adenocarcinoma of the pancreas, cholangiocarcinoma of the gallbladder, salivary gland adenocarcinoma, ovarian endometrioid adenocarcinoma, stage IV pancreatic cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic malignancy expressing CEA Metastatic disease meeting one of the following criteria: Measurable or nonmeasurable History of metastases but no current evidence of disease, meeting one of the following criteria: Unresectable peritoneal or lymph node metastases that cannot be detected by imaging Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%) Must have completed treatment that rendered no evidence of disease within the past year CEA-expressing malignancy is defined by any of the following: Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining) CEA level in peripheral blood greater than 2.5 µg/L Tumor known to be universally CEA positive (e.g., colon and rectal cancer) Received prior therapy with possible survival benefit or refused such therapy Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment 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 at least 3,000/mm^3 Absolute lymphocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times upper limit of normal No active acute or chronic viral hepatitis Hepatitis B surface antigen negative Hepatitis C negative No other hepatic disease that would preclude study entry Renal Creatinine less than 2.5 mg/dL No active acute or chronic urinary tract infection Cardiovascular No New York Heart Association class III or IV heart disease Immunologic HIV negative No history of autoimmune disease, including, but not limited to, the following: Inflammatory bowel disease Systemic lupus erythematosus Rheumatoid arthritis Ankylosing spondylitis Scleroderma Multiple sclerosis No allergy to eggs or any component of study vaccine Other No active acute or chronic infection No concurrent serious acute or chronic illness that would preclude study entry No other medical or psychological impediment that would preclude study entry No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior biologic therapy and recovered No other concurrent immunotherapy Chemotherapy At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy At least 4 weeks since prior hormonal therapy and recovered At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies No concurrent steroids Radiotherapy Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery Not specified Other At least 4 weeks since any other prior therapy (including experimental therapy) and recovered No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)

Sites / Locations

  • Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRICOM-CEA(6D)

Arm Description

Subjects receiving TRICOM-CEA(6D)

Outcomes

Primary Outcome Measures

Safety
The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.

Secondary Outcome Measures

Immune response
The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated

Full Information

First Posted
December 7, 2001
Last Updated
September 4, 2014
Sponsor
Michael Morse, MD
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00027534
Brief Title
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Official Title
A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Morse, MD
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.
Detailed Description
OBJECTIVES: Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA. Assess the CEA-specific immune response of patients treated with this regimen. Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen. OUTLINE: This is a dose-escalation study. Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity. Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 6-18 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, Gallbladder Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Ovarian Cancer, Pancreatic Cancer, Testicular Germ Cell Tumor
Keywords
recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent gallbladder cancer, unresectable gallbladder cancer, thyroid gland medullary carcinoma, recurrent salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, Paget disease of the breast with intraductal carcinoma, Paget disease of the breast with invasive ductal carcinoma, adult primary hepatocellular carcinoma, diffuse adenocarcinoma of the stomach, intestinal adenocarcinoma of the stomach, mixed adenocarcinoma of the stomach, adenocarcinoma of the colon, adenocarcinoma of the gallbladder, adenocarcinoma of the rectum, recurrent malignant testicular germ cell tumor, stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, male breast cancer, adenocarcinoma of the pancreas, cholangiocarcinoma of the gallbladder, salivary gland adenocarcinoma, ovarian endometrioid adenocarcinoma, 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
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRICOM-CEA(6D)
Arm Type
Experimental
Arm Description
Subjects receiving TRICOM-CEA(6D)
Intervention Type
Biological
Intervention Name(s)
TRICOM-CEA(6D)
Other Intervention Name(s)
recombinant fowlpox-CEA(6D)/TRICOM vaccine
Intervention Description
dendritic cells loaded with TRICOM-CEA(6D)
Primary Outcome Measure Information:
Title
Safety
Description
The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.
Time Frame
12-36 weeks
Secondary Outcome Measure Information:
Title
Immune response
Description
The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated
Time Frame
12-36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic malignancy expressing CEA Metastatic disease meeting one of the following criteria: Measurable or nonmeasurable History of metastases but no current evidence of disease, meeting one of the following criteria: Unresectable peritoneal or lymph node metastases that cannot be detected by imaging Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%) Must have completed treatment that rendered no evidence of disease within the past year CEA-expressing malignancy is defined by any of the following: Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining) CEA level in peripheral blood greater than 2.5 µg/L Tumor known to be universally CEA positive (e.g., colon and rectal cancer) Received prior therapy with possible survival benefit or refused such therapy Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment 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 at least 3,000/mm^3 Absolute lymphocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times upper limit of normal No active acute or chronic viral hepatitis Hepatitis B surface antigen negative Hepatitis C negative No other hepatic disease that would preclude study entry Renal Creatinine less than 2.5 mg/dL No active acute or chronic urinary tract infection Cardiovascular No New York Heart Association class III or IV heart disease Immunologic HIV negative No history of autoimmune disease, including, but not limited to, the following: Inflammatory bowel disease Systemic lupus erythematosus Rheumatoid arthritis Ankylosing spondylitis Scleroderma Multiple sclerosis No allergy to eggs or any component of study vaccine Other No active acute or chronic infection No concurrent serious acute or chronic illness that would preclude study entry No other medical or psychological impediment that would preclude study entry No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior biologic therapy and recovered No other concurrent immunotherapy Chemotherapy At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy At least 4 weeks since prior hormonal therapy and recovered At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies No concurrent steroids Radiotherapy Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery Not specified Other At least 4 weeks since any other prior therapy (including experimental therapy) and recovered No concurrent immunosuppressives (e.g., 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
27705
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

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