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Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00088933
Recruitment Status : Terminated
First Posted : August 5, 2004
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 4, 2004
First Posted Date  ICMJE August 5, 2004
Last Update Posted Date March 31, 2014
Study Start Date  ICMJE June 2004
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • Anti-tumor response rate defined as the number of patients in each arm achieving a complete or partial response or stable disease divided by the total number of patients on each arm measured according to standard RECIST guidelines [ Time Frame: Up to 6 years ]
  • Immune response defined as the numbers of patients who achieve an ELISPOT result of 1/30,000 or higher divided by the number of HLA-A2 positive individuals for each treatment arm [ Time Frame: Up to 6 years ]
    The actual ELISPOT will be recorded for each individual and will be presented graphically.
  • Number of patients experiencing each of the toxicities by grade for each treatment arm [ Time Frame: Up to 6 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Average quantity of circulating CEA cells determined by quantitative real time RT-PCR [ Time Frame: Up to 6 years ]
The impact of the combination therapy on CCC will be presented graphically with descriptive statistics. Will be plotted for each time point by each treatment group.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer
Official Title  ICMJE Randomized Single Institution Pilot Study of Vaccinia-CEA(6D)-TRICOM and Fowlpox-CEA(6D)-TRICOM With GM-CSF in Combination With Docetaxel in Patients With CEA-Bearing Cancers
Brief Summary This randomized phase I trial studies the side effects, best way to give, and best dose of docetaxel when given together with vaccine therapy and sargramostim in treating patients with metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow and peripheral blood. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill more tumor cells.
Detailed Description

OBJECTIVES:

I. Determine the recommended dose and schedule of docetaxel when given in combination with recombinant vaccinia-CEA-TRICOM vaccine, recombinant fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF), defined by best immune response with acceptable toxicity, in patients with carcinoembryonic antigen (CEA)-expressing metastatic lung or colorectal cancer.

II. Compare the effect of varying doses and schedules of docetaxel on CEA-specific T-cell immune responses by ELISPOT assay in patients treated with these regimens.

III. Compare objective antitumor response in patients treated with these regimens.

OUTLINE:

This is a 2-part, randomized, pilot study. Patients are randomized to 1 of 6 treatment arms: arms I, II, and III in part I (lung cancer and colorectal cancer patients) and arms IV, V, and VI in part II (lung cancer patients only). Patients are stratified according to disease site and HLA-A2 positivity (positive vs negative). At least 6 of 10 patients must be HLA-A2 positive for each of the treatment arms.

Vaccinia-CEA-TRICOM vaccine (parts I and II): In all treatment arms, patients receive vaccinia-CEA-TRICOM vaccine intradermally on day 1 and sargramostim (GM-CSF) subcutaneously (SC) into the vaccine site on days 1-4.

Fowlpox-CEA-TRICOM vaccine and concurrent chemotherapy:

Part I (lung cancer and colorectal cancer patients):

ARM 1: Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4.

ARM II: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.

ARM III: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.

Part II (lung cancer patients only):

ARM IV: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.

ARM V: Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.

ARM VI: Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.

Treatment in all arms repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients who do not have significant disease progression or unacceptable toxicity after 4 courses of treatment may receive additional fowlpox-CEA-TRICOM vaccine and docetaxel according to the treatment arm on which they were enrolled at study entry. Patients are followed every 6 months for 2 years and then annually for 13 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Extensive Stage Small Cell Lung Cancer
  • Recurrent Colon Cancer
  • Recurrent Non-small Cell Lung Cancer
  • Recurrent Rectal Cancer
  • Recurrent Small Cell Lung Cancer
  • Stage IV Colon Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Rectal Cancer
Intervention  ICMJE
  • Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
    Given intradermally
    Other Names:
    • fowlpox-CEA-B7-1/ICAM-1/LFA-3
    • rF-CEA(6D)TRICOM
  • Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
    Given intradermally
    Other Name: rV-CEA(6D)-TRICOM
  • Drug: docetaxel
    Given IV
    Other Names:
    • RP 56976
    • Taxotere
    • TXT
  • Drug: sargramostim
    Given subcutaneously
    Other Names:
    • GM-CSF
    • Leukine
    • Prokine
Study Arms  ICMJE
  • Experimental: Arm I
    Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4.
    Interventions:
    • Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
    • Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
    • Drug: sargramostim
  • Experimental: Arm II
    Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.
    Interventions:
    • Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
    • Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
    • Drug: docetaxel
    • Drug: sargramostim
  • Experimental: Arm III
    Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.
    Interventions:
    • Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
    • Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
    • Drug: docetaxel
    • Drug: sargramostim
  • Experimental: Arm IV
    Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.
    Interventions:
    • Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
    • Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
    • Drug: docetaxel
    • Drug: sargramostim
  • Experimental: Arm V
    Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.
    Interventions:
    • Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
    • Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
    • Drug: docetaxel
    • Drug: sargramostim
  • Experimental: Arm VI
    Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.
    Interventions:
    • Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
    • Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
    • Drug: docetaxel
    • Drug: sargramostim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 8, 2006)
60
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed lung OR colorectal cancer
  • Incurable metastatic disease
  • Currently available standard treatment not likely to offer a survival advantage or result in superior palliation
  • Evaluable disease by radiograph
  • Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR CEA >= 10 ng/mL at any point during disease course
  • No clinically active brain metastases
  • Must have had first- and second-line treatment OR declined second-line treatment (part I only)
  • Patients with colon cancer must have had or have been offered treatment with oxaliplatin (part I only)
  • ECOG 0-1
  • Life expectancy of at least 4 months
  • Absolute neutrophil count >= 1,500/mm^3
  • WBC >= 3,000/mm^3
  • Platelet count >= 100,000/mm^3
  • Bilirubin normal
  • Meets 1 of the following criteria:

    • SGOT and SGPT =< 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal
    • SGOT and SGPT =< normal AND alkaline phosphatase =<4.0 times ULN
  • Hepatitis B and C negative by clinical history and physical exam
  • Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min
  • Proteinuria =< grade 1
  • No known or suspected history of impaired cardiac function as evidenced by baseline echocardiogram
  • Adequate pulmonary function
  • No history or clinical evidence of immune deficiency or autoimmunity
  • HIV negative
  • No history of or concurrent diagnosis of any of the following:

    • Altered immunodeficiency
    • Eczema or other eczematoid skin disorders
    • Acute, chronic, or exfoliative skin condition (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • No history of allergy or untoward reaction to prior vaccination with vaccinia virus
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No history of allergy to eggs or egg products
  • No frequent vomiting or severe anorexia
  • No inflammatory bowel disease
  • No Crohn's disease
  • No ulcerative colitis
  • No active diverticulitis
  • Neuropathy =< grade 1 (sensory neuropathy)
  • No uncontrolled seizure disorder
  • No encephalitis
  • No multiple sclerosis
  • Must be maintaining a reasonable state of nutrition (=< 10 % weight loss in the past month)
  • Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with individuals with active or a history of eczema or other eczematoid skin disorders
  • Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with those with unresolved acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with any of the following individuals: pregnant or nursing women; children =< 5 years of age; immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • No other concurrent serious medical illness that would preclude study participation
  • No concurrent biologic therapy
  • No other concurrent immunotherapy
  • At least 6 weeks since prior nitrosoureas or mitomycin
  • Prior docetaxel allowed (part I only)
  • No prior docetaxel (part II only)
  • No other concurrent chemotherapy
  • No concurrent systemic steroids except for the following:

    • physiologic doses for systemic steroid replacement therapy
    • local (topical, nasal, or inhaled) steroid use
    • no concurrent steroid eye drops
    • premedication prior to and after docetaxel
  • No concurrent hormonal therapy
  • No prior radiotherapy to > 50 % of all nodal groups
  • More than 21 days since prior major surgery
  • No prior splenectomy
  • Recovered from prior therapy
  • At least 3-4 weeks since prior cytotoxic therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00088933
Other Study ID Numbers  ICMJE NCI-2009-00049
NCI-2009-00049 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000377574
02-452
02-452 ( Other Identifier: Lombardi Comprehensive Cancer Center at Georgetown University )
6230 ( Other Identifier: CTEP )
R01CA088972 ( U.S. NIH Grant/Contract )
P30CA051008 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Marshall Lombardi Comprehensive Cancer Center at Georgetown University
PRS Account National Cancer Institute (NCI)
Verification Date March 2013

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