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.
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
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.
- Conditions
- Breast Cancer, Ovarian Cancer
- 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.
Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks
Secondary outcomes (2)
Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks
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.
- First posted27 Jan 2003 (estimated)
- Study startJun 2000
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Samir N. Khleif, MD, Principal investigator, National Cancer Institute (NCI)
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Therapy With Tumor Specific p53 Peptides in Adult Patients With Adenocarcinoma of the Breast or Ovary
- ClinicalTrials.gov ID
- NCT00019916
- Acronym / sponsor ID
- CDR0000067279
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- Jul 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukin | Biological | – |
| p53 peptide vaccine | Biological | – |
| in vitro-treated peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Cellular immunity as measured by Elipsot assay and 51 Cr-release assay at baseline, and every 3 weeks
2 secondary outcomes
Toxicity as measured by CTC v2.0 at baseline, and every 3 weeks
Tumor response as measured by CT scan at baseline, and every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir N. Khleif, MD principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
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.