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Breast CancerPhase 1/2NCT00019916

Vaccine Therapy Plus Interleukin-2 in Treating Women With Stage IV, Recurrent, or Progressive Breast or Ovarian Cancer

A Phase 1/2 study testing aldesleukin, p53 peptide vaccine and in vitro-treated peripheral blood stem cell transplantation in people with Breast Cancer and Ovarian Cancer, run by National Cancer Institute (NCI) at 2 sites 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 may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. It is not yet known whether combining vaccine therapy with interleukin-2 is effective in treating breast and ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Ovarian Cancer
What is being tested?
aldesleukin, p53 peptide vaccine and in vitro-treated peripheral blood stem cell transplantation
Type of treatment
Vaccines, Surgery or procedure
How many people
Not given
Where
2 sitesUnited States
Study dates
Jun 2000to Jul 2006
Phase
Phase 1/2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma of the breast or ovary
  • Stage IV, recurrent, or progressive disease with no chemotherapy or radiotherapy options available that would increase survival
  • Tumor tissue available for determination of p53 protein expression and genetic mutation
  • p53-positive tumor by immunohistochemical analysis
  • HLA-A2.1 positive
  • No prior CNS metastases
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT or SGPT no greater than 4 times normal
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No myocardial infarction within past 6 months
  • No prior congestive heart failure
  • No prior ventricular arrhythmias or other arrhythmias requiring therapy

Immunologic:

  • Must have positive intradermal delayed hypersensitivity test for 1 of the following:
  • Mumps
  • Trichophyton
  • Tetanus
  • Candida
  • PPD
  • No underlying immune deficiency
  • No prior autoimmune disease including, but not limited to, the following:
  • Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
  • Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma
  • Myasthenia gravis
  • Goodpasture's syndrome
  • Addison's disease
  • Hashimoto's thyroiditis
  • Active Graves' disease
  • No active infection requiring antibiotics
  • HIV negative

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy within the past 2 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • At least 1 year since prior bone marrow transplantation

Chemotherapy:

  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Prior anticancer hormonal therapy allowed
  • At least 4 weeks since prior systemic steroids and recovered

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • Chronic suppressive antibiotics allowed

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20889

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. It is not yet known whether combining vaccine therapy with interleukin-2 is effective in treating breast and ovarian cancer.

PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and interleukin-2 and to see how well they work in treating women with stage IV, recurrent, or progressive breast or ovarian cancer.

Read the detailed description

OBJECTIVES:

  • Determine whether endogenous cellular immunity to the p53 peptide vaccine is present in patients with stage IV, recurrent, or progressive breast or ovarian cancer and whether vaccination with these peptides and low-dose interleukin-2 can induce or boost the cellular immunity in these patients.
  • Determine the type and characteristics of cellular immunity generated by this regimen in these patients.
  • Determine the toxicity of this regimen in these patients.
  • Correlate any immunologic response with any objective tumor response to this regimen in these patients.

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

All patients undergo apheresis of autologous peripheral blood mononuclear cells, which are harvested and selected for monocytes on day -6. The monocyte fraction is cultured with sargramostim (GM-CSF) and interleukin-4 for 7 days and then pulsed with p53 peptide vaccine.

  • Arm I: Patients receive p53 peptide vaccine subcutaneously (SC) on day 1.
  • Arm II: Patients receive p53 peptide vaccine IV over 5 minutes on day 1. Treatment in both arms repeats every 3 weeks for a total of 4 vaccinations (4 courses). During courses 3 and 4, patients also receive low-dose interleukin-2 (IL-2) SC daily on days 3-7 and days 10-14. Patients with stable or responding disease may continue to receive vaccine and IL-2 treatment for up to 2 years.

Patients are followed at 1 month and then every 2-4 months for 2 years.

PROJECTED ACCRUAL: A maximum of 34 patients will be accrued for this study within 2 years.

Being tested
aldesleukin, p53 peptide vaccine, in vitro-treated peripheral blood stem cell transplantation
Keywords
stage IV breast cancer, recurrent breast cancer, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • aldesleukinBiological

  • p53 peptide vaccineBiological

  • in vitro-treated peripheral blood stem cell transplantationProcedure or surgery

What is being measured

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

  1. Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks

Secondary outcomes (2)
  1. Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks

  2. Tumor response as measured by CT scan at baseline, and every 3 months

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 startJun 2000
  3. Study completionJul 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 1/2
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019916
Sponsor's protocol ID
CDR0000067279
Other IDs
NCI-99-C-0138, NCI-NMOB-9902, NCI-T99-0075
Status last verified
Dec 2005
First submitted
11 Jul 2001
Last updated
20 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing aldesleukin, p53 peptide vaccine and in vitro-treated peripheral blood stem cell transplantation in people with Breast Cancer and Ovarian Cancer, run by National Cancer Institute (NCI) at 2 sites 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks. 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 20 Jun 2013.

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