CompletedPhase 2NCT00103142

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

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.

Checked against the public recordLast updated Oct 14, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations6
SponsorMichael Morse, MD
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Michael Morse, MD
Interventions being studied
Biological: falimarev; Biological: inalimarev; Biological: sargramostim; Biological: therapeutic autologous dendritic cells
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington D.C., District of Columbia
  • H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida
  • Duke Comprehensive Cancer CenterDurham, North Carolina
  • Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina
  • Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon
  • Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 14, 2015. Always confirm current availability with the study team.

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