Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
3 other identifiers
interventional
23
1 country
1
Brief Summary
RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival. PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2006
CompletedFirst Submitted
Initial submission to the registry
February 5, 2007
CompletedFirst Posted
Study publicly available on registry
February 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedResults Posted
Study results publicly available
May 17, 2022
CompletedMay 17, 2022
April 1, 2022
14.2 years
February 5, 2007
February 25, 2022
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
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.
1 Year
Secondary Outcomes (4)
Disease-free Survival (DFS)
1 Year
Engraftment of Platelets
Day 100
Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells
Pre-Transplant
Engraftment of Neutrophils
Day 42
Study Arms (1)
2 Transplants/1 Transplant (Overall)
EXPERIMENTAL2 Transplants: Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens. 1 Transplants:Patients with Germ cell tumors who receive one transplant only.
Interventions
Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes
600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3.
2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
225 mg/m\^2 intravenous over 3 hours on Day -7.
150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4
Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)
2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
Eligibility Criteria
You may qualify if:
- Diagnosis: Poor Prognosis Non-Seminomas Germ Cell Tumor in ≥ PR1/CR1 or Good or Intermediate Prognosis Seminomas and Non- Seminomas Germ Cell Tumor in ≥ PR1 or ≥ CR2 as defined by the International Germ Cell Cancer Consensus Classification. Patients with increasing tumor markers only (i.e. no imaging evidence of progressive disease) are eligible for transplant.
- Age: ≥ 10 years and \< 70 years of age.
- Performance status: Karnofsky ≥ 80% (subjects ≥ 16 years of age) Lansky ≥ 80% for subject 10 - 15 years of age
- Life expectancy: Greater than 8 weeks.
- Patients must have normal organ function as defined below:
- Hematologic:
- Hemoglobin \> 8 gm/dL without transfusion and off erythropoietin for 14 days or Aranesp for 21 days
- White blood cells (WBC) \> 2.5 x 10\^9/L with an absolute neutrophile count (ANC) \> 1.5 x 10\^9/L and off G-CSF or GM-CSF for 10 days or Neulasta for 21 days
- Platelets \> 100 x 10\^9/L without transfusion and/or a bone marrow cellularity of ≥ 20%
- Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance \> 50 ml/min.
- Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase \< 5 x upper limit of normal. No history of severe prior or ongoing chronic liver disease.
- Cardiac: Patients must be free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia. LVEF ≥45% by MUGA/ECHO.
- Pulmonary: Patients must have no significant obstructive airways disease (FEV1 must be ≥ 50% of predicted) and must have acceptable diffusion capacity (corrected DLCO \> 50% of predicted).
- Patients with a history of CNS tumor involvement are eligible if they have completed treatment for CNS disease (radiotherapy or surgery or chemotherapy), have recovered from or stabilization of the side effects associated with the therapy and have no evidence of progressive CNS disease at the time of enrollment.
You may not qualify if:
- Patients with serious uncontrolled infections will not be eligible.
- Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during and for the duration of study participation. The drugs used in this study are pregnancy category D - clear evidence of risk in pregnancy.
- Pregnant and breast feeding women will not be eligible.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Additional Eligibility prior to Transplant Two:
- Total Collection of ≥ 4 x 10\^6 CD34 cells/kg prior to transplant one
- Transplant able to occur between day +30 and day +90 from transplant one
- Recovery of blood counts as demonstrated by:
- WBC \> 2.5 x 10\^9/L with an ANC \> 1.5 x 10\^9/L and off G-CSF for 3 days
- Platelets \> 50 x 10\^9/L without transfusion in the prior 7 days
- Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance \> 50 ml/min
- Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase \< 5 x upper limit of normal
- Infection: Patients with serious uncontrolled infections at the time of planned transplant will be excluded
- Patients with progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria by imaging techniques are not eligible to proceed to the second transplant. Tumor marker increase alone is not sufficient to diagnose disease progression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Najla El Jurdi
- Organization
- Masonic Cancer Center, University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Najla El Jurdi, MD
Masonic Cancer Center, University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2007
First Posted
February 7, 2007
Study Start
December 19, 2006
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
May 17, 2022
Results First Posted
May 17, 2022
Record last verified: 2022-04