Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
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Purpose
RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Biological: CEA peptide 1-6D |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Active Immunotherapy With CAP-1 (6D) and CMVpp65 Peptide-Pulsed, Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients With Stage IV CEA Expressing Malignancies |
- Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
- Immune response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells
| Enrollment: | 4 |
| Study Start Date: | September 2003 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CEA peptide 1-6D
CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
|
Biological: CEA peptide 1-6D
CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Other Name: carcinoembryonic antigen peptide 1-6D
|
Detailed Description:
OBJECTIVES:
- Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies.
- Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients.
- Determine the antitumor effect of this regimen, in terms of progression-free survival, of these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide 1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts.
- Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations.
- Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations.
For both cohorts, a safe dose of the vaccine is defined as the dose at which no more than 1 of 6 patients experiences unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 12 patients (6 per cohort) will be accrued for this study within 24 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit
- Stage IV disease
Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following:
- Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining
- Peripheral blood CEA greater than 2.5 mg/dL
- Tumor known to be universally CEA positive (i.e., colon or rectal cancer)
- HLA-A201 positive
Measurable disease*
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion
- Received at least 1 prior standard chemotherapy regimen known to have a survival benefit
- Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 6 months
Hematopoietic
- WBC at least 3,000/mm^3
- Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors [e.g., epoetin alfa] allowed)
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease)
- SGOT/SGPT less than 1.5 times upper limit of normal
- No hepatic disease that would preclude study participation
- No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology
Renal
- Creatinine less than 2.5 mg/dL
- No urinary tract infection
Cardiovascular
- No New York Heart Association class III or IV heart disease
Immunologic
No history of autoimmune disease, including any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Ankylosing spondylitis
- Scleroderma
- Multiple sclerosis
- No active acute or chronic infection
- HIV negative
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious chronic or acute illness that would preclude study participation
- No medical or psychological impediment that would preclude study compliance
- No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
- No allergy to study vaccine components
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy
- No other concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- At least 6 weeks since prior steroid therapy (except steroids administered as premedication for chemotherapy or contrast-enhanced studies)
- Concurrent hormonal therapy allowed for patients with breast cancer
- No concurrent steroid therapy
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- Recovered from prior therapy
- At least 4 weeks since prior investigational therapy
- At least 4 weeks since other prior therapy
- Any number of prior therapies are allowed
- Concurrent bisphosphonates allowed for bone metastases
- No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine)
- No other concurrent experimental therapies
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27705 | |
| Study Chair: | Herbert K. Lyerly, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Michael Morse, MD, Principal Investigator, Duke University |
| ClinicalTrials.gov Identifier: | NCT00057915 History of Changes |
| Other Study ID Numbers: | 4180, 5910, 4180 |
| Study First Received: | April 7, 2003 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Duke University:
|
unspecified adult solid tumor, protocol specific |
ClinicalTrials.gov processed this record on May 23, 2013