Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00728 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II trial studies how well giving combination chemotherapy and peripheral blood stem cell transplant followed by aldesleukin and sargramostim works in treating patients with inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy, such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together with sargramostim may kill more tumor cells
PRIMARY OBJECTIVES:
I. To determine the event-free survival and survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF.
SECONDARY OBJECTIVES:
II. To determine the toxicity of a combination of low-dose IL-2 and GM-CSF in patients following HDC with BUMELTT and PBSC support.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive busulfan orally (PO) once every 6 hours on days -8, -7, and -6; melphalan IV over 30 minutes on days -5 and -4; and thiotepa IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell infusion on day 0.
POST-TRANSPLANT THERAPY: All patients receive tamoxifen citrate* PO once daily beginning prior to aldesleukin (IL-2) and sargramostim (GM-CSF) therapy and continuing for 5 years or until relapse (estrogen receptor [ER]- or progesterone receptor [PR]-positive patients) OR until completion of IL-2/GM-CSF therapy (ER-negative or PR-negative patients). Eligible patients receive IL-2 subcutaneously (SC) daily and GM-CSF SC 3 times weekly for 12 weeks beginning 30-100 days after transplantation. Patients may receive radiotherapy after completion of IL-2/GM-CSF treatment if no prior radiotherapy was given before transplantation.
*Stage IV patients not receiving IL-2/GM-CSF therapy who received tamoxifen citrate as part of adjuvant therapy and subsequently failed, receive oral anastrozole once daily for 5 years or until progression instead of tamoxifen.
[*For postmenopausal patients, the choice and duration of hormonal therapy given in addition to or an alternative to tamoxifen therapy will be at the physician's discretion]
Patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | See Detailed Description. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamoxifen citrate | Drug | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival | Event-free survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF. | 11 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF. | 11 years |
| Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leona A Holmberg | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium | Seattle | Washington | 98109 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer | See Detailed Description. tamoxifen citrate: Given orally busulfan: Given orally thiotepa: Given IV melphalan: Given IV aldesleukin: Given SC sargramostim: Given SC peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| busulfan | Drug | Given orally |
|
|
| thiotepa | Drug | Given IV |
|
|
| melphalan | Drug | Given IV |
|
|
| aldesleukin | Biological | Given SC |
|
|
| sargramostim | Biological | Given SC |
|
|
| peripheral blood stem cell transplantation | Procedure | Undergo autologous peripheral blood stem cell infusion |
|
|
| radiation therapy | Radiation | May undergo radiotherapy after completion of IL-2/GM-CSF |
|
|
IL-2/GM-CSF toxicity assessed using the NCI Toxicity Criteria. Toxicity was defined as any grade 2, 3, 4 or 5 CNS (except grade 0-3 malaise and fatigue) toxicity; any grade 3, 4, or 5 non-CNS or non-hematological toxicity (except grade 0-3 bilirubin); or any grade 4 or 5 hematological toxicity. |
| 16 Weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer | See Detailed Description. tamoxifen citrate: Given orally busulfan: Given orally thiotepa: Given IV melphalan: Given IV aldesleukin: Given SC sargramostim: Given SC peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event-free Survival | Event-free survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF. | Study-wide, 20 patients out of 50 have event-free survival. | Posted | Count of Participants | Participants | 11 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF. | Posted | Count of Participants | Participants | 11 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF | IL-2/GM-CSF toxicity assessed using the NCI Toxicity Criteria. Toxicity was defined as any grade 2, 3, 4 or 5 CNS (except grade 0-3 malaise and fatigue) toxicity; any grade 3, 4, or 5 non-CNS or non-hematological toxicity (except grade 0-3 bilirubin); or any grade 4 or 5 hematological toxicity. | 28 (56%) of 50 patients started IL-2/GM-CSF immunotherapy. Stopping rules were not met for this study. | Posted | Count of Participants | Participants | 16 Weeks |
|
|
BUMELTT toxicity assessed day -8 through day 100 using the Bearman Toxicity Criteria, Grades 3 and 4. IL-2/GM-CSF toxicity over 16 weeks will be assessed using the NCI Toxicity Criteria, Grades 3 and 4.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer | See Detailed Description. tamoxifen citrate: Given orally busulfan: Given orally thiotepa: Given IV melphalan: Given IV aldesleukin: Given SC sargramostim: Given SC peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF | 32 | 50 | 2 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged hospitalization for post-transplant complications | Infections and infestations | Systematic Assessment | Transplant toxicity. |
| |
| Pulmonary Emboli | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | IL-2/GM-CSF toxicity. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelosuppression | Blood and lymphatic system disorders | Systematic Assessment | Toxicity to transplant therapy. No deaths in 1st 100 days post-transplant. |
| |
| Infections | Infections and infestations | Systematic Assessment | Toxicity to transplant therapy. No deaths in 1st 100 days post-transplant. |
| |
| Hematologic | Blood and lymphatic system disorders | Systematic Assessment | Toxicity to IL-2/GM-CSF Therapy. No deaths on therapy. |
| |
| Infection | Infections and infestations | Systematic Assessment | Toxicity to IL-2/GM-CSF Therapy. No deaths on therapy. |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leona A. Holmberg | Fred Hutchinson Cancer Research Center | 206-667-6447 | lholmber@fredhutch.org |
| ID | Term |
|---|---|
| D058922 | Inflammatory Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D002066 | Busulfan |
| D013852 | Thiotepa |
| D008558 | Melphalan |
| C082598 | aldesleukin |
| D007376 | Interleukin-2 |
| C081222 | sargramostim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|