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Adult Solid NeoplasmPhase 1NCT00217373

Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)

A Phase 1 study testing Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine, Recombinant Interferon Alfa-2b and Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine in people with Adult Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metastatic cancer that makes CEA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Solid Neoplasm
What is being tested?
Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine, Recombinant Interferon Alfa-2b and Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Jun 2005to Mar 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed carcinoembryonic antigen (CEA)-expressing carcinoma
  • Metastatic or locally advanced disease
  • Tumor accessible for biopsy
  • Must have received ≥ 1 prior systemic regimen for metastatic disease
  • No known brain metastases
  • Performance status - ECOG 0-2
Show all 62Show fewer
  • Performance status - Karnofsky 60-100%
  • More than 6 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 4.0 times ULN
  • Hepatitis B negative
  • Hepatitis C negative
  • Creatinine ≤ 1.96 mg/dL
  • Creatinine clearance > 50 mL/min
  • No persistent proteinuria
  • Protein < 1,000 mg by 24-hour urine collection
  • No urinary sediment abnormalities
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No clinically significant cardiomyopathy requiring treatment
  • No impaired function (i.e., ejection fraction < 50%) for patients who have not had prior vaccine and are asymptomatic
  • HIV negative
  • No ongoing or active infection
  • No history of allergic reaction to eggs or egg products
  • No history of allergy or untoward reaction to prior vaccinia vaccination (e.g., smallpox immunization) or to any of its components
  • No history of or active eczema or other eczematoid skin disorders
  • No atopic dermatitis
  • No other acute, chronic, or exfoliative skin conditions, including any of the following:
  • Burns
  • Impetigo
  • Varicella zoster
  • Severe acne
  • Other open wounds or rashes
  • No immunocompromised condition
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No sexual contact for 3 weeks after each vaccination treatment
  • Must be willing to undergo tumor biopsy
  • No psychiatric illness or social situation that would preclude study compliance
  • No life-threatening illness
  • No other active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder or cervical lesions treated with surgical resection
  • No other uncontrolled illness
  • Must be able to avoid close household contact with the following individuals for ≥ 3 weeks after vaccinia vaccination:
  • Pregnant or nursing women
  • Children under 5 years of age
  • Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV infection)
  • Individuals with the following conditions:
  • History of or active eczema or other eczematoid skin disorders
  • Atopic dermatitis
  • Other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • No concurrent influenza vaccine
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent steroid therapy, except topical or inhaled steroids
  • No concurrent steroid eye drops
  • More than 4 weeks since prior radiotherapy and recovered
  • More than 4 weeks since prior surgery and recovered
  • No prior splenectomy
  • No other concurrent investigational agents

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase I Study of Sequential Vaccinations With Fowlpox-CEA(6D)-Tricom (B7.1/ICAM/LFA3) and Vaccinia-CEA (6D)-Tricom, in Combination With GM-CSF and Interferon-Alfa-2B in Patients With CEA-Expressing Carcinomas

This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metastatic cancer that makes CEA. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells that make carcinoembryonic antigen (CEA). Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Interferon alfa-2b may interfere with the growth of cancer cells and slow cancer growth. Giving vaccine therapy together with GM-CSF and interferon alfa-2b may kill more cancer cells that make CEA.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose and recommended phase II dose of interferon alfa-2b (IFN-α-2b) when administered with recombinant vaccinia-CEA(6D)-TRICOM vaccine, recombinant fowlpox-CEA(6D)-TRICOM vaccine, and sargramostim (GM-CSF) in patients with locally advanced or metastatic carcinoembryonic antigen (CEA)-expressing carcinoma.

SECONDARY OBJECTIVES:

  1. Determine the effect of IFN-α-2b on tumor cell expression of CEA and MHC class I antigens in patients treated with this regimen.

II. Determine the immunologic effects of this regimen in these patients. III. Determine any objective anti-tumor responses that may occur in response to this regimen in these patients.

IV. Determine the time to tumor progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of interferon alfa-2b (IFN-α-2b).

COURSE I: Patients receive recombinant vaccinia-CEA(6D)-TRICOM vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4 and IFN-α-2b* SC on days 9, 11, and 13.

COURSES II-IV: Patients receive recombinant fowlpox-CEA(6D)-TRICOM vaccine SC on day 1. Patients also receive GM-CSF as in course 1 and IFN-α-2b* SC on days 1, 3, and 5.

NOTE: *The initial cohort of 6 patients does not receive IFN-α-2b.

Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients who do not have progressive disease or unacceptable toxicity may receive recombinant fowlpox-CEA (6D)-TRICOM vaccine, GM-CSF, and IFN-α-2b every 28 days for 2 more courses and then every 3 months for up to 2 years.

Cohorts of 3-6 patients receive escalating doses of IFN-α-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Six additional patients are treated at the MTD; these patients must be HLA-A2 positive.

After completion of study treatment, patients are followed monthly for 4 months and then every 6-12 months for up to 15 years.

Being tested
Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine, Recombinant Interferon Alfa-2b, Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine, Sargramostim

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Fowlpox-CEA(6D)/TRICOM VaccineBiological

    Also called fowlpox-CEA-B7.1/ICAM-1/LFA-3, Recombinant Fowlpox-CEA-TRICOM Vaccine, rF-CEA(6D)TRICOM

    Given SC

  • Recombinant Interferon Alfa-2bBiological

    Also called Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B

    Given SC

  • Recombinant Vaccinia-CEA(6D)-TRICOM VaccineBiological

    Also called rV-CEA(6D)-TRICOM, Vaccinia-CEA-TRICOM Vaccine

    Given SC

  • SargramostimBiological

    Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine

    Given SC

Study groups in NCT00217373
Study groupRoleWhat they receive
Arm IExperimentalCOURSE I: Patients receive recombinant vaccinia-CEA(6D)-TRICOM vaccine SC on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4 and IFN-α-2b* SC on days 9, 11, and 13. COURSES II-IV: Patients receive recombinant fowlpox-CEA(6D)-TRICOM vaccine SC on day 1. Patients also receive GM-CSF as in course 1 and IFN-α-2b* SC on days 1, 3, and 5. NOTE: *The initial cohort of 6 patients does not receive IFN-α-2b. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients who do not have progressive disease or unacceptable toxicity may receive recombinant fowlpox-CEA (6D)-TRICOM vaccine, GM-CSF, and IFN-α-2b every 28 days for 2 more courses and then every 3 months for up to 2 years.
Receives: Biological: Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine; Biological: Recombinant Interferon Alfa-2b; Biological: Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine; Biological: Sargramostim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of IFN-alpha-2b, defined as the dose level one level beneath that dose at which 2 or more of 6 patients showed DLT, graded according to NCI CTCAE version 4.0

    Measured: Up to 112 days

Secondary outcomes (2)

  1. Incidence of adverse events, graded according to NCI CTCAE version 4.0

    All patients will be evaluable for toxicity from the time of their first treatment with rF-CEA(6D)TRICOM and rV-CEA(6D)TRICOM.

    Measured: Up to 15 years

  2. Response to treatment, evaluated using the new international criteria proposed by the RECIST Committee

    Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). Patients in response categories 4-9 should be considered as failing to respond to treatment (disease progression).

    Measured: Up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionJan 2013
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217373
Sponsor's protocol ID
NCI-2011-01347
Other IDs
NCI-2011-01347, NCI-5633, OSU-2005H0005, CDR0000439532, OSU 0312, 5633, P30CA016058, U01CA076576
Status last verified
Dec 2014
First submitted
20 Sep 2005
Last updated
20 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine, Recombinant Interferon Alfa-2b and Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine in people with Adult Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 62 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of IFN-alpha-2b, defined as the dose level one level beneath that dose at which 2 or more of 6 patients showed DLT, graded according to NCI CTCAE version 4.0 (time frame: Up to 112 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00217373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.

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