Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

NCT ID: NCT00027534

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2007-10-31

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.

Conditions

Breast Cancer; Colorectal Cancer; Gallbladder Cancer; Gastric Cancer; Head and Neck Cancer; Liver Cancer; Ovarian Cancer; Pancreatic Cancer; Testicular Germ Cell Tumor

Study Design

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

Study Groups

TRICOM-CEA(6D)

Subjects receiving TRICOM-CEA(6D)

Group Type: EXPERIMENTAL

TRICOM-CEA(6D)

Intervention Type: BIOLOGICAL

dendritic cells loaded with TRICOM-CEA(6D)

Interventions

TRICOM-CEA(6D)

dendritic cells loaded with TRICOM-CEA(6D)

Intervention Type: BIOLOGICAL

Other Intervention Names

recombinant fowlpox-CEA(6D)/TRICOM vaccine

Eligibility Criteria

Inclusion 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)

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Michael Morse, MD

OTHER

Sponsor Role: lead

Responsible Party

Michael Morse, MD

Principal Investigator

Responsibility Role: SPONSOR_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

1R21CA094523

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2840

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000069041

Identifier Type: -

Identifier Source: secondary_id

2840

Identifier Type: -

Identifier Source: org_study_id