Breast CancerPhase 1NCT00002616
Biological Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer
A Phase 1 study testing aldesleukin, filgrastim and carboplatin in people with Breast Cancer, run by University of Illinois Chicago 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. Peripheral stem cell transplantation combined with biological therapy may be an effective treatment for breast cancer. Read more about this study
- Who is it for?
- Ages Up to 64 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- aldesleukin, filgrastim and carboplatin
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1995to not given
- 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 Up to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Histologically confirmed advanced breast cancer not eligible for (or patient refuses participation in) a higher priority phase III SWOG study Local stage IIIB/IV disease, i.e.: Inflammatory Fixed to chest wall Fixed to axillary lymph nodes Recurrent disease Metastatic disease Disease stable or responsive to standard dose systemic chemotherapy Measurable or evaluable disease required except: Unevaluable stage IV disease (beyond draining lymph nodes) eligible following surgical resection, radiotherapy, or chemotherapy Less than 30% bone marrow involvement on aspiration and biopsy No active brain metastases CT or MRI required unless asymptomatic and no history of brain metastases No large symptomatic pleural effusion
PATIENT CHARACTERISTICS: Age: Under 65 Performance status: SWOG 0 or 1 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% on MUGA No angina No history of myocardial infarction Exercise stress test without definite ischemia required for: History suggestive of coronary disease Diabetes mellitus Hypertension Age over 50 Pulmonary: FEV1 greater than 60% of predicted or greater than 2.0 liters DLCO greater than 60% of predicted Other: No prior hemorrhagic cystitis No active systemic infection No active CNS disease (e.g., seizures) HIV negative No second malignancy within 2 years except: Localized nonmelanomatous skin cancer Carcinoma in situ of the cervix Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy and recovered No more than 2 different prior chemotherapy regimens for metastatic disease No prior mitomycin or nitrosourea Lifetime cumulative doxorubicin dose less than 350 mg per square meter Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since radiotherapy and recovered Surgery: At least 3 weeks since major surgery and recovered
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
About this study
Official title: A PILOT TRIAL OF INTERLEUKIN-2 WITH G-CSF AS PRIMING THERAPY FOR PERIPHERAL BLOOD STEM CELL HARVESTING IN PATIENTS WITH ADVANCED BREAST CANCER: STAMP V HIGH DOSE CHEMOTHERAPY, STEM CELL INFUSION AND POST-INFUSION G-CSF AND INTERLEUKIN-2
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Peripheral stem cell transplantation combined with biological therapy may be an effective treatment for breast cancer.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 with filgrastim to stimulate cell production in treating patients with stage IIIB, stage IV, metastatic, or recurrent breast cancer who will undergo peripheral stem cell transplantation.
Read the detailed description
OBJECTIVES: I. Estimate the maximum tolerated dose of continuous infusion interleukin-2 (IL-2) that can be combined with a standard dose of filgrastim (G-CSF) to stimulate peripheral blood stem cells (PBSC) for harvest in patients with advanced breast cancer. II. Assess PBSC engraftment following high dose cyclophosphamide, thiotepa, and carboplatin (the STAMP V regimen) supported by G-CSF or IL-2/G-CSF hematopoietic support in patients who underwent the same pretransplant PBSC stimulation. III. Characterize the toxic effects of combined IL-2 and G-CSF. IV. Compare immune function changes following IL-2/G-CSF and G-CSF alone by assessing expression of CD56/CD56-bright, CD3, and CD25; natural killer cell and lymphokine activated killer cell activity; T-cell responses (TT, HER2/neu); and serum levels of interleukin-6, tumor necrosis factor, and G-CSF. V. Compare the effects on the expression of circulating hematopoietic progenitor cells (CD34+, CFU-GM, and BFU-GM) of a range of IL-2 doses when combined with G-CSF to those achieved with G-CSF alone. VI. Compare the time to neutrophil and platelet recovery, requirements for red blood cell and platelet transfusion, and time to hospital discharge in patients receiving IL-2/G-CSF-primed vs. G-CSF-primed PBSC following STAMP V chemotherapy. VII. Compare the feasibility, toxicity, and hematologic and immunologic effects of post-PBSC infusion of IL-2/G-CSF vs. G-CSF alone. VIII. Assess the response rate, duration of response, and disease free interval of patients with advanced breast cancer treated with STAMP V with PBSC rescue. IX. Assess the presence of cytokeratin as a marker of minimum residual disease when measured in blood and marrow by polymerase chain reaction during and following treatment.
OUTLINE: Patients are assigned to 1 of 4 treatment groups for peripheral blood stem cell stimulation (priming) and for therapy after stem cell transplantation. All patients receive priming therapy with filgrastim (G-CSF) alone or with interleukin-2 (IL-2), then have stem cells harvested. Patients with adequate harvest receive high dose cyclophosphamide, thiotepa, and carboplatin (STAMP V) followed by stem cell rescue with subsequent G-CSF with or without IL-2, as follows: Arm I receives G-CSF alone for priming and following stem cell transplant. Arm II receives G-CSF priming alone and G-CSF/IL-2 following transplant. Arm III receives various doses of G-CSF/IL-2 priming and G-CSF following transplant. Arm IV receives various levels of G-CSF/IL-2 priming and fixed doses of G-CSF/IL-2 following transplant. Cohorts of 3-6 patients each are treated on each treatment arm and at escalating doses of IL-2. The maximum tolerated dose is defined as the dose at which less than 2 of 6 patients experience dose limiting toxicity. Patients are followed for disease progression and survival.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study over 18-24 months; a maximum of 12 patients will receive G-CSF priming alone (6 without and 6 with post-PBSC IL-2).
- Conditions
- Breast Cancer
- Being tested
- aldesleukin, filgrastim, carboplatin, cyclophosphamide, thiotepa
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
filgrastimBiological
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 posted31 Aug 2004 (estimated)
- Study startFeb 1995
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 University of Illinois ChicagoThe 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
- Primary purpose
- Treatment
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey A. Sosman, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002616
- Sponsor's protocol ID
- CDR0000063925
- Other IDs
- UIC-95-1011, LUMC-6728, NCI-V94-0573
- Status last verified
- Sep 2000
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT TRIAL OF INTERLEUKIN-2 WITH G-CSF AS PRIMING THERAPY FOR PERIPHERAL BLOOD STEM CELL HARVESTING IN PATIENTS WITH ADVANCED BREAST CANCER: STAMP V HIGH DOSE CHEMOTHERAPY, STEM CELL INFUSION AND POST-INFUSION G-CSF AND INTERLEUKIN-2
- ClinicalTrials.gov ID
- NCT00002616
- Acronym / sponsor ID
- CDR0000063925
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Feb 1995
- First posted
- 31 Aug 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. Peripheral stem cell transplantation combined with biological therapy may be an effective treatment for breast cancer.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 with filgrastim to stimulate cell production in treating patients with stage IIIB, stage IV, metastatic, or recurrent breast cancer who will undergo peripheral stem cell transplantation.
Detailed description
OBJECTIVES: I. Estimate the maximum tolerated dose of continuous infusion interleukin-2 (IL-2) that can be combined with a standard dose of filgrastim (G-CSF) to stimulate peripheral blood stem cells (PBSC) for harvest in patients with advanced breast cancer. II. Assess PBSC engraftment following high dose cyclophosphamide, thiotepa, and carboplatin (the STAMP V regimen) supported by G-CSF or IL-2/G-CSF hematopoietic support in patients who underwent the same pretransplant PBSC stimulation. III. Characterize the toxic effects of combined IL-2 and G-CSF. IV. Compare immune function changes following IL-2/G-CSF and G-CSF alone by assessing expression of CD56/CD56-bright, CD3, and CD25; natural killer cell and lymphokine activated killer cell activity; T-cell responses (TT, HER2/neu); and serum levels of interleukin-6, tumor necrosis factor, and G-CSF. V. Compare the effects on the expression of circulating hematopoietic progenitor cells (CD34+, CFU-GM, and BFU-GM) of a range of IL-2 doses when combined with G-CSF to those achieved with G-CSF alone. VI. Compare the time to neutrophil and platelet recovery, requirements for red blood cell and platelet transfusion, and time to hospital discharge in patients receiving IL-2/G-CSF-primed vs. G-CSF-primed PBSC following STAMP V chemotherapy. VII. Compare the feasibility, toxicity, and hematologic and immunologic effects of post-PBSC infusion of IL-2/G-CSF vs. G-CSF alone. VIII. Assess the response rate, duration of response, and disease free interval of patients with advanced breast cancer treated with STAMP V with PBSC rescue. IX. Assess the presence of cytokeratin as a marker of minimum residual disease when measured in blood and marrow by polymerase chain reaction during and following treatment.
OUTLINE: Patients are assigned to 1 of 4 treatment groups for peripheral blood stem cell stimulation (priming) and for therapy after stem cell transplantation. All patients receive priming therapy with filgrastim (G-CSF) alone or with interleukin-2 (IL-2), then have stem cells harvested. Patients with adequate harvest receive high dose cyclophosphamide, thiotepa, and carboplatin (STAMP V) followed by stem cell rescue with subsequent G-CSF with or without IL-2, as follows: Arm I receives G-CSF alone for priming and following stem cell transplant. Arm II receives G-CSF priming alone and G-CSF/IL-2 following transplant. Arm III receives various doses of G-CSF/IL-2 priming and G-CSF following transplant. Arm IV receives various levels of G-CSF/IL-2 priming and fixed doses of G-CSF/IL-2 following transplant. Cohorts of 3-6 patients each are treated on each treatment arm and at escalating doses of IL-2. The maximum tolerated dose is defined as the dose at which less than 2 of 6 patients experience dose limiting toxicity. Patients are followed for disease progression and survival.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study over 18-24 months; a maximum of 12 patients will receive G-CSF priming alone (6 without and 6 with post-PBSC IL-2).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
| filgrastim | 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 20 Sep 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.
Jeffrey A. Sosman, MD study chair
Vanderbilt-Ingram Cancer 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 study testing aldesleukin, filgrastim and carboplatin in people with Breast Cancer, run by University of Illinois Chicago 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 20 Sep 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?
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 20 Sep 2013.