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This study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous stem cell rescue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) | Experimental | Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx). | Drug | Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | To estimate response rate after at least two and up to four courses of induction chemotherapy with GemPOx regimen in patients with recurrent intracranial MMGCT | 16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy |
| The Rate of Completion of Induction Chemotherapy and Progression to High-dose Chemotherapy (HDC) With Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR) | Mean follow-up of 44 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS and PFS | To assess the overall survival (OS) and event-free survival (EFS) of patients treated on the GemPOx induction regimen followed by the HDC and AuHPCR in patients with progressive or recurrent CNS GCT. We hypothesize that specific CSF miRNA will prove to be accurate markers for tumor presence and predictors of response to therapy, with normalization being associated with improved progression-free survival (PFS) in patients under treatment for recurrent central nervous system (CNS) germ cell tumors (GCT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randal Olshefski, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Hospital Los Angeles |
Nine patients with confirmed relapsed or refractory intracranial GCT were enrolled after signing informed consent, and received at least two cycles of GemPOx, of which all but one had relapsed or refractory NGGCTs. One patient with progressive disease was found to have pathologically confirmed malignant transformation to pure embryonal rhabdomyosarcoma (without GCT elements), hence was ineligible and not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) | Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT). Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).: Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) | Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT). Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).: Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT. Nine patients with confirmed relapsed or refractory intracranial GCT were enrolled after signing informed consent, and received at least two cycles of GemPOx, of which all but one had relapsed or refractory NGGCTs. One patient with progressive disease was found to have pathologically confirmed malignant transformation to pure embryonal rhabdomyosarcoma (without GCT elements), hence was ineligible and not included in the analysis. Patients who experienced sufficient responses proceeded to receive HDCx with AuHPCR. Treatment response was determined based on radiographic tumor assessments and tumor markers. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 10 patients were consented and enrolled on therapy; one patient was declared ineligible on path review therefore not included in the final analysis or manuscript. 9 patients total will be included in final analyses. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate | To estimate response rate after at least two and up to four courses of induction chemotherapy with GemPOx regimen in patients with recurrent intracranial MMGCT | Posted | Count of Participants | Participants | 16-32 weeks depending on individual patient response (remaining disease burden) to chemotherapy |
|
|
Each participant was followed for up to 5 months for adverse events (up to 4 cycles of Induction chemotherapy followed by one cycle of Consolidation therapy), or 30 days after the last dose of study drug was received. All-Cause Mortality was assessed for an average of 44 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) | Two to four cycles of induction therapy with open label GemPOx followed by consolidation and autologous stem cell transplant (ASCT). Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx): Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Blue | Nationwide Children's Hospital | 614-722-3686 | megan.blue@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2017 | Aug 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| 2 years, 3 years and 5 years |
| Los Angeles |
| California |
| 90027 |
| United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Ohio State University Wexner Medical Center_The James Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients enrolled on study with eligible diagnosis of CNS GCT including pure germinoma and MMGCT | Count of Participants | Participants |
|
|
| Primary | The Rate of Completion of Induction Chemotherapy and Progression to High-dose Chemotherapy (HDC) With Autologous Hematopoietic Progenitor Cell Rescue (AuHPCR) | Posted | Count of Participants | Participants | Mean follow-up of 44 months |
|
|
|
| Secondary | OS and PFS | To assess the overall survival (OS) and event-free survival (EFS) of patients treated on the GemPOx induction regimen followed by the HDC and AuHPCR in patients with progressive or recurrent CNS GCT. We hypothesize that specific CSF miRNA will prove to be accurate markers for tumor presence and predictors of response to therapy, with normalization being associated with improved progression-free survival (PFS) in patients under treatment for recurrent central nervous system (CNS) germ cell tumors (GCT). | Posted | Number | 95% Confidence Interval | Percentage of patients | 2 years, 3 years and 5 years |
|
|
|
| Post-Hoc | Last Patient Follow-up Outcome | The outcome of each patient at the last point of follow-up | Posted | Count of Participants | Participants | Months in follow-up (up to 86 months follow-up) |
|
|
|
| 4 |
| 10 |
| 2 |
| 10 |
| 10 |
| 10 |
| Death | General disorders | Non-systematic Assessment | Encephalopathy |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| ALT | Investigations | Non-systematic Assessment | The CRC wrote "ALT" but the only CTCAE term is Alanine aminotransferase increased - therefore, this is likely the true terminology |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| AST | Investigations | Non-systematic Assessment | The CRC wrote "AST" but the only CTCAE term for this is Aspartate aminotransferase increased |
|
| Confusion | Psychiatric disorders | Non-systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| GGT | Investigations | Non-systematic Assessment | The CRC wrote "GGT" but the CTCAE term is "GGT increased" |
|
| Hemoglobin | Investigations | Non-systematic Assessment | The CRC wrote "hemoglobin" but the CTCAE is "hemoglobin increased" |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Infections and infestations, other | Infections and infestations | Non-systematic Assessment | One of the two AEs says "fungal sepsis" |
|
| Low WBC | Investigations | Non-systematic Assessment | The CRC wrote "Low WBC" but the CTCAE term is "White blood count decreased" |
|
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | Non-systematic Assessment | Unknown location for mucositis based on CRC term |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain, oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Platelet count decrease | Investigations | Non-systematic Assessment |
|
| Ptosis | Eye disorders | Non-systematic Assessment | CRC wrote "ptosis" but CTCAE lists "eyelid functioning disorder" |
|
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| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| Title | Measurements |
|---|---|
|
| 2-year OS |
|
| 3-year OS |
|
| 5-year OS |
|
| NED, No Evidence of Disease |
|
| DOD, Dead of Disease |
|
| Unknown, Lost to Follow-up |
|