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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00088933
First received: August 4, 2004
Last updated: March 28, 2014
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
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
Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine
Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine
Drug: docetaxel
Drug: sargramostim
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average quantity of circulating CEA cells determined by quantitative real time RT-PCR [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: June 2004
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: sargramostim
Given subcutaneously
Other Names:
  • GM-CSF
  • Leukine
  • Prokine
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
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
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
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
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
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
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
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
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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088933

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
Sponsors and Collaborators
Investigators
Principal Investigator: John Marshall Lombardi Comprehensive Cancer Center at Georgetown University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00088933     History of Changes
Other Study ID Numbers: NCI-2009-00049, NCI-2009-00049, CDR0000377574, 02-452, 02-452, 6230, R01CA088972, P30CA051008
Study First Received: August 4, 2004
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Metronidazole
Docetaxel
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents

ClinicalTrials.gov processed this record on April 16, 2014