Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

NCT ID: NCT00057915

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-09-30

Brief Summary

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CEA peptide 1-6D

CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

Group Type: EXPERIMENTAL

CEA peptide 1-6D

Intervention Type: BIOLOGICAL

CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

Interventions

CEA peptide 1-6D

CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

Intervention Type: BIOLOGICAL

Other Intervention Names

carcinoembryonic antigen peptide 1-6D

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Michael Morse, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herbert K. Lyerly, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

5910

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4180

Identifier Type: OTHER

Identifier Source: secondary_id

4180

Identifier Type: -

Identifier Source: org_study_id