- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027534
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TRICOM-CEA(6D)
Subjects receiving TRICOM-CEA(6D)
|
dendritic cells loaded with TRICOM-CEA(6D)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 12-36 weeks
|
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.
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12-36 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune response
Time Frame: 12-36 weeks
|
The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated
|
12-36 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage II malignant testicular germ cell tumor
- stage III malignant testicular germ cell tumor
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- adenocarcinoma of the rectum
- stage IV rectal cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- recurrent colon cancer
- recurrent rectal cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- stage III colon cancer
- male breast cancer
- stage IIIC breast cancer
- stage IV pancreatic cancer
- stage IV gastric cancer
- recurrent gastric cancer
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- unresectable gallbladder cancer
- recurrent gallbladder cancer
- stage III gastric cancer
- ovarian endometrioid adenocarcinoma
- cholangiocarcinoma of the gallbladder
- salivary gland adenocarcinoma
- stage III rectal cancer
- stage III pancreatic cancer
- recurrent malignant testicular germ cell tumor
- stage II pancreatic cancer
- adult primary hepatocellular carcinoma
- thyroid gland medullary carcinoma
- Paget disease of the breast with invasive ductal carcinoma
- adenocarcinoma of the gallbladder
- Paget disease of the breast with intraductal carcinoma
- diffuse adenocarcinoma of the stomach
- intestinal adenocarcinoma of the stomach
- mixed adenocarcinoma of the stomach
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Breast Diseases
- Liver Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Biliary Tract Neoplasms
- Stomach Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Breast Neoplasms
- Pancreatic Neoplasms
- Liver Neoplasms
- Gallbladder Neoplasms
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Metronidazole
Other Study ID Numbers
- 2840 (Other Identifier: Duke IRB)
- 1R21CA094523 (U.S. NIH Grant/Contract)
- CDR0000069041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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