Trial Outcomes & Findings for Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer (NCT NCT00003199)
NCT ID: NCT00003199
Last Updated: 2017-07-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
11 years
Results posted on
2017-07-12
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Refused Post-Transplant Immunotherapy
|
5
|
|
Overall Study
Lack of insurance clearance
|
2
|
|
Overall Study
Screen fail
|
15
|
Baseline Characteristics
Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
n=50 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 11 yearsPopulation: Study-wide, 20 patients out of 50 have 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.
Outcome measures
| Measure |
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
n=50 Participants
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
|
|---|---|
|
Event-free Survival
Stage IIIB Disease
|
11 Participants
|
|
Event-free Survival
Stage IV Disease
|
9 Participants
|
SECONDARY outcome
Timeframe: 11 yearsOverall 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.
Outcome measures
| Measure |
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
n=50 Participants
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
|
|---|---|
|
Overall Survival
|
18 Participants
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: 28 (56%) of 50 patients started IL-2/GM-CSF immunotherapy. Stopping rules were not met for this study.
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.
Outcome measures
| Measure |
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
n=28 Participants
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
|
|---|---|
|
Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF
|
6 Participants
|
Adverse Events
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
Serious events: 2 serious events
Other events: 50 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
n=50 participants at risk
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
|
|---|---|
|
Infections and infestations
Prolonged hospitalization for post-transplant complications
|
2.0%
1/50 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Emboli
|
2.0%
1/50 • 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.
|
Other adverse events
| Measure |
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
n=50 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Myelosuppression
|
100.0%
50/50 • 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.
|
|
Infections and infestations
Infections
|
32.0%
16/50 • 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.
|
|
Blood and lymphatic system disorders
Hematologic
|
21.4%
6/28 • 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.
|
|
Infections and infestations
Infection
|
10.7%
3/28 • 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.
|
Additional Information
Dr. Leona A. Holmberg
Fred Hutchinson Cancer Research Center
Phone: 206-667-6447
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place