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NCT00432094 · REGISTRY CONDITION SEARCH

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2022-05-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Disease-free Survival (DFS)

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outcome · POSTED

Engraftment of Platelets

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outcome · POSTED

Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells

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outcome · POSTED

Engraftment of Neutrophils

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
healthy Volunteers
false
maximum Age
69 Years
minimum Age
10 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    2 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.
    intervention Names
    1. Drug: carboplatin
    2. Drug: etoposide
    3. Drug: ifosfamide
    4. Drug: paclitaxel
    5. Drug: thiotepa
    6. Procedure: autologous hematopoietic stem cell transplantation
    7. Drug: Mesna
    8. Biological: filgrastim
    label
    2 Transplants/1 Transplant (Overall)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    Days -6, -5, -4: 500mg/m2\^/day intravenously (IV) over 60 minutes
    name
    carboplatin
    type
    DRUG
  2. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    600mg/m\^2/day intravenously (IV) over 60 minutes on Days -6 through -3.
    name
    etoposide
    other Names
    1. VP-16
    2. Toposar
    type
    DRUG
  3. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
    name
    ifosfamide
    other Names
    1. Mitoxana
    2. Ifex
    type
    DRUG
  4. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    225 mg/m\^2 intravenous over 3 hours on Day -7.
    name
    paclitaxel
    other Names
    1. Taxol
    type
    DRUG
  5. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    150mg/m\^2/day intravenously IV over 30 minutes; Days -6, -5 and -4
    name
    thiotepa
    other Names
    1. N,N'N'-triethylenethiophosphoramide
    type
    DRUG
  6. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    Peripheral blood stem cell infusion (\< 4 x 10\^6 CD34+ cells/kg)
    name
    autologous hematopoietic stem cell transplantation
    other Names
    1. PBSC
    type
    PROCEDURE
  7. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    2500 mg/m\^2/day continuous infusion intravenously on Days -6, -5 and -4.
    name
    Mesna
    other Names
    1. Uromitexan®
    type
    DRUG
  8. arm Group Labels
    1. 2 Transplants/1 Transplant (Overall)
    description
    Beginning Day 5, G-CSF 5 μg/kg/day until absolute neutrophil count (ANC) ≥ 1500/UL for 3 consecutive days.
    name
    filgrastim
    other Names
    1. G-CSF
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
intervention Model Description
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.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
23
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Overall Survival (OS)
    time Frame
    1 Year
secondary Outcomes
  1. description
    The number of patients who survive without any signs of symptions of that cancer or any other cancer.
    measure
    Disease-free Survival (DFS)
    time Frame
    1 Year
  2. description
    Platelet engraftment is defined as 20,000/mm\^3 (20 x 10\^9/L) for 3 consecutive days unsupported by a platelet transfusion.
    measure
    Engraftment of Platelets
    time Frame
    Day 100
  3. description
    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.
    measure
    Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells
    time Frame
    Pre-Transplant
  4. description
    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.
    measure
    Engraftment of Neutrophils
    time Frame
    Day 42
Full study description
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.
detailed Description
OBJECTIVES: Primary * Determine overall survival (OS) of patients with germ cell tumors treated with tandem autologous stem cell transplantation with non-cross-resistant conditioning regimens. Secondary * Determine disease-free survival (DFS) of patients treated with this regimen. * Determine the toxicity of tandem transplants * Determine the time to engraftment of neutrophils and platelets in patients treated for each transplant * Determine the number of patients unable to adequately mobilize sufficient peripheral blood stem cells (PBSC) for tandem transplantation. * Identify prognostic factors of patients unlikely to mobilize sufficient PBSC for tandem transplantation. * Compare OS and DFS of patients undergoing single vs tandem transplantation. OUTLINE: * Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF): Patients receive G-CSF subcutaneously (SC) beginning on day 1 and continuing until stem cell collection is complete. Patients undergo stem cell collection beginning on day 5 of G-CSF administration and continuing for at least 3 collections until the collection goal is met. * Second PBSC mobilization with chemotherapy: Patients not meeting the collection goal receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 4 and continuing until stem cell collection is complete. Patients meeting the collection goal after PBSC mobilization via G-CSF alone or in combination with chemotherapy will undergo tandem autologous transplantation. If collection goal is not met but the patient has collected \> or = 2 x 10\^6 CD34 cells/kg, a single autologous transplant will be performed. * Single stem cell transplantation (SCT): Patients receive paclitaxel IV over 3 hours on day -7 and ifosfamide IV on days -6 to -4. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 1 and continuing until blood counts recover. * Tandem SCT: Patients receive treatment as in single SCT. Beginning 30-90 days later, patients receive carboplatin IV over 60 minutes and thiotepa IV over 30 minutes on days -6 to -4 and etoposide IV over 60 minutes on days -6 to -3. Patients undergo reinfusion of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. After completion of study treatment, patients are followed at 6, 9, and 12 months and then every 6 months for up to 2 years. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice