Colon Cancer Clinical Trial

Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer

Summary

RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.

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Full Description

OBJECTIVES:

Primary

Compare 2-year disease-free survival of patients with completely resected hepatic or pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine therapy comprising vaccinia-Carcinoembryonic antigen (CEA)-mucin 1 (MUC-1)- Triad of costimulatory molecules TRICOM vaccine (PANVAC-V) and fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic cells or with sargramostim (GM-CSF).

Secondary

Compare the rate and magnitude of immune response, as determined by enzyme-linked immunosorbent spot (ELISpot), in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
Arm II: Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.

After completion of study treatment, patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 2 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma of the colon and rectum

Must have undergone complete resection of hepatic or pulmonary metastases with curative intent

No evidence of gross residual disease after surgery
One or more resected and ablated lesions allowed provided all gross residual tumor was destroyed by ablation
Repeated resections of hepatic metastatic disease or resections of extrahepatic metastases prior to resection of the hepatic metastases allowed provided the most recent hepatic metastatic resection included total disease resection and/or ablation
Must have received at least 2 months of perioperative systemic chemotherapy (including preoperative and/or postoperative chemotherapy) that was completed at least 1 month ago

PATIENT CHARACTERISTICS:

Age

At least 18

Performance status

Karnofsky 70-100%

Life expectancy

At least 6 months

Hematopoietic

Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 8.5 g/dL (transfusion or epoetin alfa allowed)

Hepatic

Bilirubin ≤ 2.0 mg/dL
Hepatitis B surface antigen negative
Hepatitis C antibody negative
No other serious chronic or acute hepatic disease

Renal

Creatinine ≤ 1.5 mg/dL OR
Creatinine clearance > 60 mL/min

Cardiovascular

No New York Heart Association class III or IV cardiac disease
No other serious chronic or acute cardiac disease

Pulmonary

No asthma
No chronic obstructive pulmonary disease
No other serious chronic or acute pulmonary disease

Immunologic

No history of autoimmune disease, including, but not limited to, any of the following:

Inflammatory bowel disease
Systemic lupus erythematosus
Ankylosing spondylitis
Scleroderma
Multiple sclerosis
No human immunodeficiency virus (HIV) infection by enzyme-linked immunosorbent assay (ELISA) and western blot
Not immunocompromised (by disease or therapy)
No allergy to eggs or any component of the study vaccine
No history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination
No allergy or untoward reaction to sargramostim (GM-CSF)
No active acute or chronic infection, including urinary tract infection within the past 72 hours

No inflammatory bowel conditions, including, but not limited to, the following:

Active infectious enteritis
Eosinophilic enteritis

No acute, chronic, or exfoliative skin disorders, including any of the following:

Extensive psoriasis
Burns
Impetigo
Disseminated zoster
Varicella zoster
Severe acne
Other open rashes or wounds

Other

Not pregnant or nursing
Fertile patients must use effective contraception

Able to avoid close contact or household contact for 3 weeks after each vaccination with the following individuals:

Children under 5 years of age
Pregnant or nursing women
Individuals with prior or concurrent extensive eczema, other eczematoid skin disorders, or other acute or chronic skin conditions
Immunosuppressed or immunodeficient individuals
No medical or psychological condition that would preclude study compliance
No extensive eczema
No other serious chronic or acute illness that would preclude study participation
No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled superficial bladder cancer, or previously treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

No other concurrent immunotherapy

Chemotherapy

See Disease Characteristics
No concurrent chemotherapy

Endocrine therapy

More than 6 weeks since prior and no concurrent steroid therapy

Radiotherapy

No concurrent radiotherapy

Surgery

See Disease Characteristics

Other

No other concurrent immunosuppressants (e.g., azathioprine or cyclosporine)

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

74

Study ID:

NCT00103142

Recruitment Status:

Completed

Sponsor:

Michael Morse, MD

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There are 6 Locations for this study

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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa Florida, 33612, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

74

Study ID:

NCT00103142

Recruitment Status:

Completed

Sponsor:


Michael Morse, MD

How clear is this clinincal trial information?

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