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Vaccine Therapy and Radiation Therapy in Treating Patients With Carcinoembryonic Antigen-Positive Solid Tumors That Have Metastasized to the Liver
This study is ongoing, but not recruiting participants.
Study NCT00085241   Information provided by National Cancer Institute (NCI)
First Received: June 10, 2004   Last Updated: July 11, 2009   History of Changes

June 10, 2004
July 11, 2009
April 2004
 
Safety by CTC AE version 3.0 [ Designated as safety issue: Yes ]
Safety by CTC AE version 3.0
Complete list of historical versions of study NCT00085241 on ClinicalTrials.gov Archive Site
  • Objective response by RECIST every 2 months [ Designated as safety issue: No ]
  • Compare immunologic response by ELISPOT at baseline and day 91 [ Designated as safety issue: No ]
  • Objective response by RECIST every 2 months
  • Compare immunologic response by ELISPOT at baseline and day 91
 
Vaccine Therapy and Radiation Therapy in Treating Patients With Carcinoembryonic Antigen-Positive Solid Tumors That Have Metastasized to the Liver
A Pilot Trial Of A CEA-Tricom Based Vaccine And Radiation To Liver Metastasis In Adults With CEA Positive Solid Tumors

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining vaccine therapy and radiation therapy may kill more tumor cells.

PURPOSE: This clinical trial is studying how well giving vaccine therapy together with radiation therapy works in treating patients with carcinoembryonic antigen-positive solid tumors that have metastasized to the liver.

OBJECTIVES:

Primary

  • Determine the clinical safety of vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, recombinant fowlpox GM-CSF vaccine, and radiotherapy in patients with carcinoembryonic antigen (CEA)-positive solid tumors metastatic to the liver.

Secondary

  • Determine the clinical response in patients receiving this regimen.
  • Determine the immunological response, specifically the CEA-specific T-cell response, in patients receiving this regimen.
  • Determine the effect of radiotherapy (before and after treatment) on FAS, major histocompatability complex, p53, and CEA in these patients.

OUTLINE: Patients receive a priming vaccination of vaccinia (rV)-CEA-TRICOM and recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine subcutaneously (SC) on day 1. Patients receive a booster vaccination of fowlpox (rF)-CEA-TRICOM and rF-GM-CSF SC on days 21, 35, 49, and 63. Patients undergo radiotherapy on days 22-25, 36-39, 50-53, and 64-67. Patients with stable disease or objective response after day 91 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed annually for 15 years.

PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.

 
Interventional
Treatment
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Metastatic Cancer
  • Pancreatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: recombinant fowlpox GM-CSF vaccine adjuvant
  • Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine
  • Biological: recombinant vaccinia-CEA(6D)-TRICOM vaccine
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
16
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of solid tumor

    • Radiographically visible metastatic liver lesions that are life-threatening
    • Carcinoembryonic antigen (CEA)-positive disease that meets one of the following criteria:

      • ≥ 20% of cells stained immunohistochemically
      • Elevated serum CEA (> 5 ng/mL) at any time during disease course
  • Received at least 1 prior chemotherapy regimen for metastatic disease
  • Vaccinia-naïve OR vaccinia-immune
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Absolute lymphocyte count ≥ 400/mm^3

Hepatic

  • See Disease Characteristics
  • AST ≤ 2 times upper limit of normal
  • Bilirubin normal (≤ 3 times ULN with Gilbert's syndrome)
  • PT and PTT normal
  • Hepatitis B and C negative
  • No chronic liver disease, including the following:

    • End stage cirrhosis
    • Chronic active hepatitis by surface antigen or core antibody test

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No New York Heart Association class II-IV heart disease
  • No evidence of congestive heart failure by physical exam or imaging
  • No clinically significant cardiomyopathy requiring treatment

Pulmonary

  • No pulmonary disease with fatigue or dyspnea after ordinary physical activity

Immunological

  • No autoimmune disease, including the following:

    • Addison's disease
    • Hashimoto's thyroiditis
    • Systemic lupus erythematous
    • Sjögren syndrome
    • Scleroderma
    • Myasthenia gravis
    • Goodpasture syndrome
    • Active Grave's disease
  • HIV negative
  • No allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen
  • No serious hypersensitivity reaction to egg products

Other

  • During and for at least 3 weeks after vaccinia vaccination, patients or their close household contacts must not have contact with the following individuals:

    • Individuals with active or a history of eczema or other eczematoid skin disorders
    • Individuals with acute, chronic, or exfoliative skin disorders, including any of the following until the condition resolves:

      • Atopic dermatitis
      • Burns
      • Impetigo
      • Varicella zoster
      • Severe acne
      • Other open rashes or wounds
    • Pregnant or nursing women
    • Children ≤ 5 years of age
    • Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV-infected individuals)
  • No concurrent serious medical illness that would preclude study compliance, including, but not limited to, the following:

    • Inflammatory bowel disease
    • Crohn's disease
    • Ulcerative colitis
    • Active diverticulitis
  • No history of seizures, encephalitis, or multiple sclerosis
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • Prior immunotherapy allowed
  • No other concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent systemic steroids except physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroids
  • At least 2 weeks since prior steroid eye drops
  • No concurrent steroid eye drops during and for 4 weeks after vaccinia vaccination
  • No concurrent hormone therapy
  • No concurrent dexamethasone or other steroid as an antiemetic

Radiotherapy

  • No prior radiotherapy to > 50% of all nodal groups
  • No prior radiotherapy to the whole liver
  • No other concurrent radiotherapy

Surgery

  • No prior splenectomy
  • No concurrent major surgery

Other

  • Recovered from all prior therapy
  • At least 4 weeks since prior cytotoxic therapy
  • No concurrent aprepitant
  • No other concurrent anticancer therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00085241
 
CDR0000367490, NCI-04-C-0167, NCI-6368
National Cancer Institute (NCI)
 
Principal Investigator: James L. Gulley, MD, PhD, FACP National Cancer Institute (NCI)
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP