- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00429182
Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer
Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Carboplatin and thiotepa are designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die. Mesna is designed to prevent toxicities from cyclophosphamide. Granulocyte colony-stimulating factor (G-CSF or GCSF) is designed to help your white blood count recover after transplant.
If you are found to be eligible to take part in this study, you will be given G-CSF twice a day through a needle under the skin (subcutaneous injection), on Days 1-5. On Day 5, stem cell collection will begin. You will have a catheter placed into a vein in your chest. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your physician will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
If further shrinkage of tumor is needed, the doctor may use chemotherapy combined with G-CSF described above. Your doctor will explain this procedure to you in more detail, and you will be asked to sign a separate consent form for this procedure.
Blood will be removed from your body through the catheter and passed through a machine that separates the stem cells from the other cells. The stem cells will be frozen for storage, and the blood will be returned to your body. This 3-hour process is called apheresis. The process will be done once a day for 1-6 days until enough stem cells are collected. Blood ( about 4 teaspoons) will be collected at the first Apheresis to have as a comparison sample to check for any breast cancer leftover in the blood.
The collected blood cells will go through a filter to select out the blood stem cells and the CTCs will be left behind.
Blood (about 2 tablespoons) will be drawn daily during peripheral blood stem cell collection.
On Days 6, 5, 4, and 3 before the transplant, you will receive cyclophosphamide, mesna, thiotepa, and carboplatin through a needle in your vein. Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 0, your stem cells will be transplanted. Stem cells will go through a device to remove the breast cancer cells. If the bone marrow is collected because there was not enough stem cells, researchers will not treat the bone marrow to remove breast cancer cells. Collected breast cancer cells will be studied to understand the biological role of these cancer cells.
After the transplant, G-CSF will be given through a needle under your skin until the white blood cell count is normal for 3 days in a row.
Blood (about 2 tablespoons) will be drawn daily after the transplant while you are still in the hospital. You are expected to remain in the hospital for 3 weeks. Once you are released from the hospital, you will have blood (about 2 tablespoons) drawn for routine tests every week until your cell counts recover.
Five (5) weeks after your transplant, if your doctor thinks it is needed, you will have radiation therapy, hormonal therapy, or receive trastuzumab.
At Months 1, 3, 6, 9, 12, 16, 20, and 24 after the transplant, your complete medical history will be recorded, and you will have a physical exam. You will have a chest X-ray and bone scan. If your doctor thinks it is needed, you will have an x-ray of hot spots which are areas that show positive on the bone scan. If your doctor thinks it is needed, you may have a CT scan of the head, a mammogram, or a breast ultrasound performed. At Months 1 and 3 after the transplant, you will have a PET/CT scan. At Months 6, 9, 12, 16, 20, and 24 after the transplant, you will have a CT scan of the chest and abdomen then as needed to check the status of the disease. Blood (about 2 teaspoons) will be drawn to measure cancer markers and CTCs.
While on study you must notify the doctor of any new drugs you are taking.
This is an investigational study. The transplant is not FDA approved. The drugs G-CSF, cyclophosphamide, carboplatin, and thiotepa are all approved by the FDA and commercially available. The CliniMACS device is not commercially available or FDA approved. The CliniMACS device is being used in research only and will be provided free of charge. Up to 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- UT MD Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 to 55 years old
- Metastatic breast carcinoma.
- Histological confirmation of invasive breast carcinoma
- Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.
- Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR).
- Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy.
- Zubrod performance status 0 or 1.
- Patients must have adequate hematological parameters (White Blood Count/WBC >= 3,000/mm3; platelet count >= 100,000/mm3)
- Adequate renal function (serum creatinine <= 1.5mg/dl)
- Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase (SGPT) <= 2 times normal).
- Adequate cardiac function (Left ventricular ejection fraction (LVEF)>= 50%).
- Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of predicted value).
- Females of childbearing (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent) potential must use adequate contraception.
- Patients must sign an informed consent.
Exclusion Criteria:
- Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting.
- History or presence of brain/leptomeningeal metastasis.
- History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.
- Presence of other severe medical illnesses or conditions. Severe heart disease, (myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD, asthma,etc). Renal failure and hepatic failure.
- Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections).
- HIV infection.
- Pregnant or lactating women.
- Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
|
Target Area Under the Curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Andre navne:
1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Andre navne:
120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant on Day 0.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products
Tidsramme: Baseline to 1 month post AHST
|
Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.
|
Baseline to 1 month post AHST
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Median Progression Free Survival (PFS)
Tidsramme: Overall study (baseline to disease progression)
|
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
PFS time measured in months.
|
Overall study (baseline to disease progression)
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hudsygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Brystsygdomme
- Neoplastiske processer
- Neoplasma Metastase
- Brystneoplasmer
- Karcinom
- Neoplastiske celler, cirkulerende
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Cyclofosfamid
- Carboplatin
- Thiotepa
Andre undersøgelses-id-numre
- 2006-0280
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Brystkræft
-
Cairo UniversityIkke rekrutterer endnu
-
Abouqir General HospitalAlexandria UniversityRekrutteringBreast Udseende Rekonstruktion DisproportionEgypten
-
ETOP IBCSG Partners FoundationAfsluttetBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAfsluttetBreast Cancer Invasive NosSpanien
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbejdspartnereAfsluttetDen kliniske anvendelsesvejledning af Conebeam Breast CTKina
-
Ontario Clinical Oncology Group (OCOG)Afsluttet
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...UkendtBRCA1 mutation | Breast Cancer Invasive NosPolen
-
Aga Khan UniversityAfsluttetBrystkræft | Perforatorklap | Brysttumor | Oncoplasty | Breast-QPakistan
-
University Health Network, TorontoAfsluttetBreast Cancer Invasive Nos | Primær invasiv brystkræftCanada
-
KU LeuvenNovartisUkendtER Positive, HER2 Negative Breast Cancer NeoplasmaBelgien
Kliniske forsøg med Carboplatin
-
Eisai Inc.AfsluttetKræftForenede Stater, Østrig, Indien
-
NHS Greater Glasgow and ClydeAfsluttetLivmoderhalskræft | Æggelederkræft | Primær peritoneal kræftDet Forenede Kongerige, Australien, New Zealand
-
Duke UniversityAfsluttetTumorer i hjernen og centralnervesystemetForenede Stater, Canada
-
Samyang Biopharmaceuticals CorporationAfsluttet
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor hos voksne, protokolspecifikForenede Stater
-
Eli Lilly and CompanyAfsluttetLungeneoplasmerForenede Stater
-
National Cancer Institute (NCI)Children's Oncology GroupAfsluttetTumorer i hjernen og centralnervesystemetForenede Stater, Canada, Puerto Rico, Australien, Holland, New Zealand, Schweiz
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUkendtIntraokulært retinoblastomIndien
-
National Cancer Institute (NCI)AfsluttetBrystkræft | LivmoderhalskræftForenede Stater
-
Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCAfsluttetTestikulær kimcelletumorDet Forenede Kongerige, Canada, Norge, Holland, Sydafrika, Brasilien, Finland