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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00057915

Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

A Phase 1 study testing CEA peptide 1-6D in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University 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

RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CEA peptide 1-6D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Sep 2003to Sep 2006
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit
  • Stage IV disease
  • Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following:
  • Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining
  • Peripheral blood CEA greater than 2.5 mg/dL
  • Tumor known to be universally CEA positive (i.e., colon or rectal cancer)
  • HLA-A201 positive
  • Measurable disease*
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion
  • Received at least 1 prior standard chemotherapy regimen known to have a survival benefit
  • Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 6 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors [e.g., epoetin alfa] allowed)
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease)
  • SGOT/SGPT less than 1.5 times upper limit of normal
  • No hepatic disease that would preclude study participation
  • No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology

Renal

  • Creatinine less than 2.5 mg/dL
  • No urinary tract infection

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Immunologic

  • No history of autoimmune disease, including any of the following:
  • Inflammatory bowel disease
  • Systemic lupus erythematosus
  • Ankylosing spondylitis
  • Scleroderma
  • Multiple sclerosis
  • No active acute or chronic infection
  • HIV negative

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious chronic or acute illness that would preclude study participation
  • No medical or psychological impediment that would preclude study compliance
  • No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
  • No allergy to study vaccine components

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior immunotherapy
  • No other concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • At least 6 weeks since prior steroid therapy (except steroids administered as premedication for chemotherapy or contrast-enhanced studies)
  • Concurrent hormonal therapy allowed for patients with breast cancer
  • No concurrent steroid therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • Recovered from prior therapy
  • At least 4 weeks since prior investigational therapy
  • At least 4 weeks since other prior therapy
  • Any number of prior therapies are allowed
  • Concurrent bisphosphonates allowed for bone metastases
  • No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine)
  • No other concurrent experimental therapies

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: A Phase I Study of Active Immunotherapy With CAP-1 (6D) and CMVpp65 Peptide-Pulsed, Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients With Stage IV CEA Expressing Malignancies

RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer.

Read the detailed description

OBJECTIVES:

  • Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies.
  • Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients.
  • Determine the antitumor effect of this regimen, in terms of progression-free survival, of these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide 1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts.

  • Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations.
  • Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations.

For both cohorts, a safe dose of the vaccine is defined as the dose at which no more than 1 of 6 patients experiences unacceptable toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 12 patients (6 per cohort) will be accrued for this study within 24 months.

Being tested
CEA peptide 1-6D
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

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

  • CEA peptide 1-6DBiological

    Also called carcinoembryonic antigen peptide 1-6D

    CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

Study groups in NCT00057915
Study groupRoleWhat they receive
CEA peptide 1-6DExperimentalCAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Receives: Biological: CEA peptide 1-6D

What is being measured

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

  1. Safety

    The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

    Measured: 12 months

Secondary outcomes (1)
  1. Immune response

    The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells

    Measured: 12 weeks

Timeline

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

  1. First posted9 Apr 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionAug 2006
  4. Study completionSep 2006

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057915
Sponsor's protocol ID
4180
Other IDs
5910, 4180
Status last verified
Sep 2014
First submitted
7 Apr 2003
Last updated
8 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CEA peptide 1-6D in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Duke University 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?

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 8 Sep 2014. 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?

Safety (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Sep 2014.

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