Trial Outcomes & Findings for Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors (NCT NCT00432094)

NCT ID: NCT00432094

Last Updated: 2022-05-17

Results Overview

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2022-05-17

Participant Flow

Participant milestones

Measure	2 Transplants Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.	1 Transplant Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
Overall Study STARTED	14	9
Overall Study COMPLETED	14	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

Baseline characteristics by cohort

Measure	2 Transplants/1 Transplant Arms (Overall) n=23 Participants Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.
Age, Continuous	31 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

Outcome measures

Measure	2 Transplants n=14 Participants Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.	1 Transplant n=9 Participants Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
Overall Survival (OS)	86 percentage of participants Interval 54.0 to 96.0	56 percentage of participants Interval 20.0 to 80.0

SECONDARY outcome

Timeframe: 1 Year

Population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

The number of patients who survive without any signs of symptions of that cancer or any other cancer.

Outcome measures

Measure	2 Transplants n=14 Participants Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.	1 Transplant n=9 Participants Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
Disease-free Survival (DFS)	64 percentage of participants Interval 34.0 to 83.0	44 percentage of participants Interval 14.0 to 72.0

SECONDARY outcome

Timeframe: Day 100

Population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

Platelet engraftment is defined as 20,000/mm^3 (20 x 10^9/L) for 3 consecutive days unsupported by a platelet transfusion.

Outcome measures

Measure	2 Transplants n=14 Participants Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.	1 Transplant n=9 Participants Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
Engraftment of Platelets	13 participants	8 participants

SECONDARY outcome

Timeframe: Pre-Transplant

Population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

Number of patients unable to achieve adequate stem cell mobilization, need to undergo one or tandem transplantation. Stem cell mobilization = A process in which certain drugs are used to cause the movement of stem cells from the bone marrow into the blood. The stem cells can be collected and stored. They may be used later to replace the bone marrow during a stem cell transplant.

Outcome measures

Measure	2 Transplants n=14 Participants Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.	1 Transplant n=9 Participants Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 42

Population: The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups.

Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater.

Outcome measures

Measure	2 Transplants n=14 Participants Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. carboplatin: Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes etoposide: 600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3. thiotepa: 150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4 autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.	1 Transplant n=9 Participants Patients with Germ cell tumors who receive one transplant only. ifosfamide: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. paclitaxel: 225 mg/m\^2 intravenous over 3 hours on Day -7. autologous hematopoietic stem cell transplantation: Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg) Mesna: 2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4. filgrastim: Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
Engraftment of Neutrophils	13 Participants	9 Participants

Adverse Events

2 Transplants/1 Transplant Arms (Overall)

Serious events: 8 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Measure	2 Transplants/1 Transplant Arms (Overall) n=23 participants at risk Patients with Germ Cell Tumors (GCT) treated with one and second autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. Adverse events are not separable by number of transplants because they were not recorded in to the University of Minnesota's CTMS system. Below you will see AEs for patients with 1 and 2 transplants pooled together.
Investigations Relapse	26.1% 6/23 • Number of events 7 • All-Cause Mortality monitored/assessed for 1 year. Serious and Other (Not Including Serious) Adverse Events monitored/assessed for 100 days after cell infusion. This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants. This trial is not a two arm protocol.
Investigations Progressive Disease	13.0% 3/23 • Number of events 3 • All-Cause Mortality monitored/assessed for 1 year. Serious and Other (Not Including Serious) Adverse Events monitored/assessed for 100 days after cell infusion. This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants. This trial is not a two arm protocol.
Investigations Death	4.3% 1/23 • Number of events 1 • All-Cause Mortality monitored/assessed for 1 year. Serious and Other (Not Including Serious) Adverse Events monitored/assessed for 100 days after cell infusion. This trial is single arm study and it is non-randomized. Overall, if patients did not have enough cells to do two transplants then they only received one transplants. This trial is not a two arm protocol.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Najla El Jurdi

Masonic Cancer Center, University of Minnesota

Phone: 612-625-8942

Email: neljurdi@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place