Breast CancerPhase 1/2NCT00002780
Biological Therapy in Treating Women With Metastatic Breast Cancer
A Phase 1/2 study testing aldesleukin, cytokine therapy and sargramostim in people with Breast Cancer, run by St. Luke's Medical Center at 1 site in United States.
Trial summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- aldesleukin, cytokine therapy and sargramostim
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 1996to not given
- 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 documented metastatic adenocarcinoma of the breast Concurrent intraductal or lobular carcinoma in situ allowed Bilateral disease allowed Measurable or evaluable recurrent metastatic disease (Stage IIIB or IV) documented by radiograph, CT scan, nuclear medicine scan, or physical exam Tumor must be clinically chemosensitive as documented by a reduction in tumor burden No clinical evidence of brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin less than 1.5 times normal Hepatitis B surface antigen negative Renal: Creatinine less than 1.8 mg/dL Creatinine clearance normal Blood urea nitrogen (BUN) less than 1.5 times normal Cardiovascular: Ejection fraction at least 45% by MUGA No uncontrolled or significant cardiovascular disease including myocardial infarction (less than 1 year) or congestive heart failure Pulmonary: PFT-FEV1 at least 60% of predicted DLCO and FVC at least 60% of predicted Other: Not pregnant Negative pregnancy test HIV negative No serious medical or psychiatric illness No prior or concurrent malignancy, other than curatively treated carcinoma in situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent hormonal therapy for breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: INFUSION OF ACTIVATED T CELLS AND LOW DOSE INTERLEUKIN 2 COMBINED WITH PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR THE TREATMENT OF WOMEN WITH METASTATIC BREAST CANCER: PHASE I/II
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of T cells and interleukin-2 combined with peripheral stem cell transplantation or bone marrow transplantation in treating women who have stage IIIB or metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Evaluate the toxicities of the combination of low dose interleukin-2 (IL-2) sargramostim (GM-CSF), and multiple doses of activated T cells (ATC) following peripheral blood stem cell transplantation in women with stage IIIB or metastatic adenocarcinoma of the breast. II. Evaluate the efficacy of this regimen in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days prior to peripheral blood stem cell (PBSC) collection or for 2 days prior to bone marrow harvest. Following PBSC collection or bone marrow harvest, patients receive high dose chemotherapy consisting of cyclophosphamide IV, carboplatin IV, and thiotepa IV over days -6 through -3. Patients undergo PBSC transplantation on day 0. Following PBSC transplantation, patients receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour between days 1 and 65, continuous low dose interleukin-2 (IL-2) IV over days 1-65, and sargramostim (GM-CSF) subcutaneously on days 5-21. Patients are followed at day 100, as clinically indicated, and then annually.
PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study within 1-2 years.
- Conditions
- Breast Cancer
- Being tested
- aldesleukin, cytokine therapy, sargramostim, carboplatin, cyclophosphamide
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
cytokine therapyBiological
sargramostimBiological
carboplatinDrug
cyclophosphamideDrug
thiotepaDrug
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2004 (estimated)
- Study startMay 1996
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.
- 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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- John P. Hanson, MD, Study chair, St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002780
- Sponsor's protocol ID
- CDR0000064792
- Other IDs
- STLMC-BRM-9503, NCI-V96-0902
- Status last verified
- Feb 2001
- First submitted
- 1 Nov 1999
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFUSION OF ACTIVATED T CELLS AND LOW DOSE INTERLEUKIN 2 COMBINED WITH PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR THE TREATMENT OF WOMEN WITH METASTATIC BREAST CANCER: PHASE I/II
- ClinicalTrials.gov ID
- NCT00002780
- Acronym / sponsor ID
- CDR0000064792
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Luke's Medical CenterUniversity, hospital or other
- Study start
- May 1996
- First posted
- 24 May 2004 (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: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of T cells and interleukin-2 combined with peripheral stem cell transplantation or bone marrow transplantation in treating women who have stage IIIB or metastatic breast cancer.
Detailed description
OBJECTIVES: I. Evaluate the toxicities of the combination of low dose interleukin-2 (IL-2) sargramostim (GM-CSF), and multiple doses of activated T cells (ATC) following peripheral blood stem cell transplantation in women with stage IIIB or metastatic adenocarcinoma of the breast. II. Evaluate the efficacy of this regimen in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days prior to peripheral blood stem cell (PBSC) collection or for 2 days prior to bone marrow harvest. Following PBSC collection or bone marrow harvest, patients receive high dose chemotherapy consisting of cyclophosphamide IV, carboplatin IV, and thiotepa IV over days -6 through -3. Patients undergo PBSC transplantation on day 0. Following PBSC transplantation, patients receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour between days 1 and 65, continuous low dose interleukin-2 (IL-2) IV over days 1-65, and sargramostim (GM-CSF) subcutaneously on days 5-21. Patients are followed at day 100, as clinically indicated, and then annually.
PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study within 1-2 years.
Study design
- Primary purpose
- Treatment
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 | – |
| cytokine therapy | Biological | – |
| sargramostim | Biological | – |
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| thiotepa | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
John P. Hanson, MD study chair
St. Luke's Medical Center
1 site 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, cytokine therapy and sargramostim in people with Breast Cancer, run by St. Luke's Medical Center 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: status not confirmed, as of the sponsor's last update on 19 Dec 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 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?
Results are not available in the source record.
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.
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 19 Dec 2013.