Trial Outcomes & Findings for High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors (NCT NCT00936936)
NCT ID: NCT00936936
Last Updated: 2024-08-26
Results Overview
Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
2 Years
Results posted on
2024-08-26
Participant Flow
All participants were registered in MD Anderson Cancer Center.
Participant milestones
| Measure |
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide (ICE) + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
23
|
|
Overall Study
Cycle 1
|
41
|
23
|
|
Overall Study
Cycle 2
|
29
|
23
|
|
Overall Study
COMPLETED
|
29
|
19
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide (ICE) + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
|
Overall Study
Disease Progression
|
2
|
2
|
|
Overall Study
Unrelated
|
3
|
1
|
Baseline Characteristics
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
n=41 Participants
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
n=23 Participants
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
23 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 YearsEvent-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.
Outcome measures
| Measure |
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
n=41 Participants
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
n=23 Participants
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
|---|---|---|
|
Number of Participants With 2-year Event-Free Survival (EFS)
|
28 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 year post treatmentNumber of Participants alive and disease free 1 year post treatment completion.
Outcome measures
| Measure |
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
n=41 Participants
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
n=23 Participants
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
|---|---|---|
|
Overall Survival
|
25 Participants
|
9 Participants
|
Adverse Events
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
Serious events: 7 serious events
Other events: 41 other events
Deaths: 22 deaths
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
Serious events: 2 serious events
Other events: 23 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
n=41 participants at risk
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
n=23 participants at risk
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
|---|---|---|
|
Investigations
ALT increased
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Investigations
AST increased
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Infections and infestations
Bacterial
|
17.1%
7/41 • Number of events 7 • 2 years
|
0.00%
0/23 • 2 years
|
|
Blood and lymphatic system disorders
Bleeding (no GI no PUL)
|
9.8%
4/41 • Number of events 4 • 2 years
|
0.00%
0/23 • 2 years
|
|
Cardiac disorders
Ejection fraction decreased
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Investigations
Creatinine increased
|
4.9%
2/41 • Number of events 2 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
|
Infections and infestations
Fungal
|
14.6%
6/41 • Number of events 6 • 2 years
|
0.00%
0/23 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
4.9%
2/41 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
|
Gastrointestinal disorders
Oral Mucositis
|
4.9%
2/41 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
|
Infections and infestations
Viral
|
4.9%
2/41 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
DAH
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/41 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/41 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
n=41 participants at risk
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
n=23 participants at risk
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Stem Cell Transplant: Stem cell infusion on Day 0.
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell Transplant: Stem cell infusion on Day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
2/41 • Number of events 2 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
GI OTH
|
2.4%
1/41 • Number of events 1 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Hallucination
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
7.3%
3/41 • Number of events 3 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.3%
3/41 • Number of events 3 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Vascular disorders
Hypertension
|
63.4%
26/41 • Number of events 26 • 2 years
|
17.4%
4/23 • Number of events 4 • 2 years
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
|
Investigations
T bilirubin increased
|
87.8%
36/41 • Number of events 36 • 2 years
|
56.5%
13/23 • Number of events 13 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/41 • Number of events 1 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
26.8%
11/41 • Number of events 11 • 2 years
|
0.00%
0/23 • 2 years
|
|
Investigations
ALK increased
|
9.8%
4/41 • Number of events 4 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
|
Immune system disorders
Allergic reaction
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Investigations
ALT increased
|
100.0%
41/41 • Number of events 70 • 2 years
|
95.7%
22/23 • Number of events 22 • 2 years
|
|
Investigations
AST increased
|
14.6%
6/41 • Number of events 6 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
|
Infections and infestations
Bacterial
|
90.2%
37/41 • Number of events 37 • 2 years
|
60.9%
14/23 • Number of events 14 • 2 years
|
|
Nervous system disorders
Peripheral neuropathy
|
12.2%
5/41 • Number of events 5 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
34.1%
14/41 • Number of events 14 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
92.7%
38/41 • Number of events 47 • 2 years
|
17.4%
4/23 • Number of events 4 • 2 years
|
|
Renal and urinary disorders
renal failure & fluid retention
|
7.3%
3/41 • Number of events 3 • 2 years
|
0.00%
0/23 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
46.3%
19/41 • Number of events 19 • 2 years
|
0.00%
0/23 • 2 years
|
|
Skin and subcutaneous tissue disorders
SK DES
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
4.9%
2/41 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin Disorders
|
92.7%
38/41 • Number of events 63 • 2 years
|
0.00%
0/23 • 2 years
|
|
Blood and lymphatic system disorders
Bleeding (no GI no PUL)
|
17.1%
7/41 • Number of events 7 • 2 years
|
0.00%
0/23 • 2 years
|
|
Blood and lymphatic system disorders
HSCT related microangiopathy (TA-TMA)
|
4.9%
2/41 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
92.7%
38/41 • Number of events 63 • 2 years
|
100.0%
23/23 • Number of events 32 • 2 years
|
|
Cardiac disorders
Dysrhythmia
|
22.0%
9/41 • Number of events 9 • 2 years
|
0.00%
0/23 • 2 years
|
|
Cardiac disorders
Chest pain
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Psychiatric disorders
Confusion
|
12.2%
5/41 • Number of events 5 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
|
Investigations
Creatinine increased
|
65.9%
27/41 • Number of events 27 • 2 years
|
69.6%
16/23 • Number of events 16 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
19.5%
8/41 • Number of events 8 • 2 years
|
0.00%
0/23 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.3%
3/41 • Number of events 3 • 2 years
|
0.00%
0/23 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Cardiac disorders
Ejection fraction decreased
|
2.4%
1/41 • Number of events 1 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
4.9%
2/41 • Number of events 2 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
General disorders
Fever
|
85.4%
35/41 • Number of events 35 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
General disorders
Flu like syndrome
|
2.4%
1/41 • Number of events 1 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
General disorders
Fluid overload
|
92.7%
38/41 • Number of events 58 • 2 years
|
100.0%
23/23 • Number of events 23 • 2 years
|
|
Infections and infestations
Fungal
|
34.1%
14/41 • Number of events 14 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
2.4%
1/41 • Number of events 1 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Oral mucositis
|
92.7%
38/41 • Number of events 87 • 2 years
|
100.0%
23/23 • Number of events 35 • 2 years
|
|
Gastrointestinal disorders
Lower Gl track obstruction
|
2.4%
1/41 • Number of events 1 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
92.7%
38/41 • Number of events 78 • 2 years
|
100.0%
23/23 • Number of events 41 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
4.9%
2/41 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
|
Nervous system disorders
Tremor
|
2.4%
1/41 • Number of events 1 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Infections and infestations
Viral
|
39.0%
16/41 • Number of events 16 • 2 years
|
21.7%
5/23 • Number of events 5 • 2 years
|
|
General disorders
DAH
|
2.4%
1/41 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/41 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/41 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
Additional Information
Dr. Yago Nieto, PhD. / Stem Cell Transplantation Department
University of Texas MD Anderson Cancer Center
Phone: 713-792-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place