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TerminatedNCT00088933Updated Mar 31, 2014

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

A Phase 1 interventional study of recombinant fowlpox-CEA(6D)/TRICOM vaccine and recombinant vaccinia-CEA(6D)-TRICOM vaccine in Extensive Stage Small Cell Lung Cancer, Recurrent Colon Cancer and Recurrent Non-small Cell Lung Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-31.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Colonic Neoplasms

1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.

This study's enrollment of 60 is below the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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.

    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.

    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.

    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.

    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.

    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.

    Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine · Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine · Drug: docetaxel · Drug: sargramostim

Interventions

  • Drugrecombinant fowlpox-CEA(6D)/TRICOM vaccine

    Drug page: Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine

    Given intradermally

    Also known as: fowlpox-CEA-B7-1/ICAM-1/LFA-3, rF-CEA(6D)TRICOM

  • Drugrecombinant vaccinia-CEA(6D)-TRICOM vaccine

    Given intradermally

    Also known as: rV-CEA(6D)-TRICOM

  • Given IV

    Also known as: RP 56976, Taxotere, TXT

  • Given subcutaneously

    Also known as: GM-CSF, Leukine, Prokine

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

    The actual ELISPOT will be recorded for each individual and will be presented graphically.

    Time frame: Up to 6 years

  3. Number of patients experiencing each of the toxicities by grade for each treatment arm

    Time frame: Up to 6 years

Secondary outcomes

  1. Average quantity of circulating CEA cells determined by quantitative real time RT-PCR

    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.

    Time frame: Up to 6 years

07

Study locations

1 site
  • Lombardi Comprehensive Cancer Center at Georgetown University
    Washington D.C., District of Columbia 20057, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00088933
Responsible party
Sponsor
First posted
Aug 5, 2004
Start date
Jun 2004
Primary completion
Nov 2007
Last update
Mar 31, 2014

Study contacts

John Marshall
principal investigator · Lombardi Comprehensive Cancer Center at Georgetown University
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Docetaxel

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