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Adenocarcinoma of the ColonPhase 1NCT00028496

Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer

A Phase 1 study testing recombinant fowlpox-CEA(6D)/TRICOM vaccine, sargramostim and recombinant fowlpox GM-CSF vaccine adjuvant in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Gallbladder, 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

Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Vaccines may make the body build an immune response to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
recombinant fowlpox-CEA(6D)/TRICOM vaccine, sargramostim and recombinant fowlpox GM-CSF vaccine adjuvant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
Nov 2001to Nov 2005
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 adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8weeks
  • Advanced or metastatic disease
  • Recurrent or unresectable disease
  • Microscopic metastatic disease confirmed by surgical exploration allowed
  • CEA expression by immunohistochemistry
  • Circulating CEA greater than 5 ng/mL
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  • HLA phenotyping required
  • HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation
  • No clinically symptomatic brain metastases
  • Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-1
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST and ALT less than 3 times ULN
  • PT and PTT less than 1.5 times ULN (unless therapeutically anticoagulated)
  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min
  • Proteinuria or hematuria less than +2 on urinalysis*
  • Urine protein less than 1,000 mg/24-hour collection, if proteinuria greater than +1
  • No frequent vomiting or severe anorexia
  • No more than 10% weight loss within the past 3 months
  • No inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis
  • No uncontrolled seizure disorders
  • No encephalitis
  • No multiple sclerosis
  • No allergy to eggs
  • No HIV-associated opportunistic infection
  • No autoimmune diseases, including the following:
  • Systemic lupus erythematosus
  • Sjögren's syndrome
  • Scleroderma
  • Myasthenia gravis
  • Goodpasture syndrome
  • Addison's disease
  • Hashimoto's thyroiditis
  • Graves' disease
  • Antinuclear antibody positive status allowed if no evidence of an autoimmune disease
  • No direct contact of vaccination site with the following persons for at least 72 hours after each vaccination:
  • Children under 1 year of age
  • Pregnant women
  • Individuals with eczema or other open skin condition
  • Immunocompromised individuals
  • No other concurrent serious medical illness that would preclude study entry
  • No other malignancy within the past 2 years except excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 month before (female patients only), during, and for at least 3 months after study participation
  • See Disease Characteristics
  • No prior CEA-directed active immunotherapy
  • Prior CEA-directed antibody therapy allowed
  • At least 4 weeks since prior immunotherapy and recovered
  • No other concurrent antineoplastic biologic therapy or immunotherapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent antineoplastic chemotherapy
  • See Disease Characteristics
  • No concurrent antineoplastic hormonal therapy
  • No concurrent systemic steroids (inhaled steroids allowed)
  • Concurrent systemic mineralocorticoids (e.g., megestrol for appetite stimulation or fludrocortisone) allowed
  • Concurrent birth control pills allowed
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 50% of all nodal groups
  • See Disease Characteristics
  • Recovered from prior surgery
  • No prior splenectomy
  • Concurrent non-steroidal anti-inflammatory drugs allowed
  • No other concurrent anti-cancer therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: Phase I Study of a Recombinant Fowl Pox Vaccine rF-CEA (6D)/TRICOM Alone or With GM-CSF in Patients With Advanced CEA Expressing Adenocarinomas

Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the toxicity of recombinant fowlpox-CEA-TRICOM vaccine with or without sargramostim (GM-CSF) or recombinant fowlpox-GM-CSF in patients with advanced or metastatic CEA-expressing adenocarcinomas.

II. Determine the CEA-specific T-cell precursor frequency in patients treated with these regimens.

III. Assess the immunogenicity of GM-CSF in patients treated with these regimens.

IV. Determine the inflammatory response and cytokine expression at the vaccination site in these patients 48 hours after vaccination.

  1. Correlate telomere length of leukocytes with prior cytotoxic therapies and immunologic response in patients treated with these regimens.

OUTLINE: This is a dose-escalation study. The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine (fCEA-TRI) until the maximum tolerated dose (MTD) is determined.

The MTD is defined as the dose preceding that at which 2 of 6 patients or 3 of 12 patients experience dose-limiting toxicity. fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter (beginning on day 56) in the absence of disease progression or unacceptable toxicity.

The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim (GM-CSF). GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days.

The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF (rF-GM-CSF). rF-GM-CSF is administered in the same manner as GM-CSF.

Patients are followed every month for 4 months.

Being tested
recombinant fowlpox-CEA(6D)/TRICOM vaccine, sargramostim, recombinant fowlpox GM-CSF vaccine adjuvant
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Hepatocellular, Breast Neoplasms, Male, Breast Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Testicular Neoplasms

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, rF-CEA(6D)TRICOM

    Given intradermally

  • sargramostimBiological

    Also called GM-CSF, Leukine, Prokine

    Given subcutaneously

  • recombinant fowlpox GM-CSF vaccine adjuvantBiological

    Also called fowlpox-GM-CSF, fowlpox-sargramostim, rf-GM-CSF, rf-sargramostim

    Given intradermally

Study groups in NCT00028496
Study groupRoleWhat they receive
Treatment (vaccine therapy, sargramostim, vaccine adjuvant)ExperimentalThe first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine (fCEA-TRI) until the maximum tolerated dose (MTD) is determined. fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter (beginning on day 56) in the absence of disease progression or unacceptable toxicity. The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim (GM-CSF). GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days. The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF (rF-GM-CSF).
Receives: Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine; Biological: sargramostim; Biological: recombinant fowlpox GM-CSF vaccine adjuvant

What is being measured

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

  1. Maximum tolerated dose of recombinant fowlpox-CEA(6D)/TRICOM vaccine determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria, version 2.0

    Measured: 56 days

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 2001
  3. Primary completionNov 2005

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028496
Sponsor's protocol ID
NCI-2012-02433
Other IDs
FCCC-01016, CDR0000069093
Status last verified
Jan 2013
First submitted
4 Jan 2002
Last updated
25 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant fowlpox-CEA(6D)/TRICOM vaccine, sargramostim and recombinant fowlpox GM-CSF vaccine adjuvant in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Gallbladder, 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 71 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 25 Jan 2013. 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?

Maximum tolerated dose of recombinant fowlpox-CEA(6D)/TRICOM vaccine determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria, version 2.0 (time frame: 56 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 NCT00028496.

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 25 Jan 2013.

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