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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.
First Received: June 10, 2004   Last Updated: July 11, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085241
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Treatment
Official Title: A Pilot Trial Of A CEA-Tricom Based Vaccine And Radiation To Liver Metastasis In Adults With CEA Positive Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety by CTC AE version 3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: April 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085241

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: James L. Gulley, MD, PhD, FACP National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000367490, NCI-04-C-0167, NCI-6368
Study First Received: June 10, 2004
Last Updated: July 11, 2009
ClinicalTrials.gov Identifier: NCT00085241     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
liver metastases
unspecified adult solid tumor, protocol specific
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the lung
adenocarcinoma of the pancreas
adenocarcinoma of the rectum
recurrent pancreatic cancer
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent breast cancer
stage IV breast cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Rectal Diseases
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Neoplasm Metastasis
Breast Diseases
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Skin Diseases
Endocrine System Diseases
Breast Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009