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

NCT00103142 | Completed Phase 2 Results DMC

• 3 other identifiers: Pro00007616DUMC-5883-04-6ROCDR000041079
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

liver metastases; adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer; adenocarcinoma of the rectum; recurrent rectal cancer; stage IV rectal cancer; lung metastases

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival at 2 Years

  Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.

  2 years

Secondary Outcomes (1)

• Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay

  13 weeks

Study Arms (2)

PANVAC-V + PANVAC-F + DC

EXPERIMENTAL

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 SC and ID on days 28, 56, and 84.

Biological: falimarev; Biological: inalimarev; Biological: therapeutic autologous dendritic cells

PANVAC-V + PANVAC-F + GM-CSF

EXPERIMENTAL

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.

Biological: falimarev; Biological: inalimarev; Biological: sargramostim

Interventions

falimarev BIOLOGICAL

Given subcutaneously and intradermally

PANVAC-V + PANVAC-F + DC; PANVAC-V + PANVAC-F + GM-CSF

inalimarev BIOLOGICAL

Given subcutaneously and intradermally

PANVAC-V + PANVAC-F + DC; PANVAC-V + PANVAC-F + GM-CSF

sargramostim BIOLOGICAL

Given subcutaneously

PANVAC-V + PANVAC-F + GM-CSF

therapeutic autologous dendritic cells BIOLOGICAL

Given subcutaneously and intradermally

PANVAC-V + PANVAC-F + DC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Michael Morse, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Morse MA, Niedzwiecki D, Marshall JL, Garrett C, Chang DZ, Aklilu M, Crocenzi TS, Cole DJ, Dessureault S, Hobeika AC, Osada T, Onaitis M, Clary BM, Hsu D, Devi GR, Bulusu A, Annechiarico RP, Chadaram V, Clay TM, Lyerly HK. A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer. Ann Surg. 2013 Dec;258(6):879-86. doi: 10.1097/SLA.0b013e318292919e.

  PMID: 23657083 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michael Morse
• Organization: Duke University Medical Center

michael.morse@dm.duke.edu

919-684-5705

Study Officials

• Michael A. Morse, MD

  Duke Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: February 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: March 1, 2013
• Last Updated: October 14, 2015
• Results First Posted: April 7, 2014

Record last verified: 2015-10

Locations

US (6)