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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-06077 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.
OBJECTIVES:
OUTLINE: This is a phase I, dose-escalation study of paclitaxel, carboplatin, and ifosfamide followed by a phase II, open-label study.
Phase I:
Cohorts of 3-6 patients receive escalating doses of paclitaxel, carboplatin, and ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 1 year and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy with Stem Cell Support | Experimental | This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Response | Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary) Complete Response (CR): A complete response is defined as one of the following:
| 2 year |
| Maximum Tolerated Dose of Ifosfamide | 4 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed germ cell tumor (GCT)
Unidimensionally measurable disease OR elevated serum tumor markers (alpha-fetoprotein and/or human chorionic gonadotropin)
Advanced disease
Known residual disease after post-chemotherapy surgery allowed
PATIENT CHARACTERISTICS:
Platelet count ≥ 100,000/mm^3
WBC ≥ 3,000/mm^3
Creatinine clearance > 50 mL/min (unless due to tumor obstructing the ureters)
AST and ALT < 2 times upper limit of normal (ULN)
Bilirubin < 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
Negative serology for HIV type I and II, human T-lymphotropic virus type I and II, hepatitis B or C virus, syphilis, and cytomegalovirus
Adequate medical condition for general anesthesia
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Feldman, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy With Stem Cell Support | This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38. filgrastim carboplatin ifosfamide paclitaxel autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ifosfamide | Drug |
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| paclitaxel | Drug |
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| autologous hematopoietic stem cell transplantation | Procedure |
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| peripheral blood stem cell transplantation | Procedure |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy With Stem Cell Support | This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38. filgrastim carboplatin ifosfamide paclitaxel autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary) Complete Response (CR): A complete response is defined as one of the following:
| Posted | Number | participants | 2 year |
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| Primary | Maximum Tolerated Dose of Ifosfamide | Posted | Number | mg/m2 | 4 years |
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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 | Chemotherapy With Stem Cell Support | This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38. filgrastim carboplatin ifosfamide paclitaxel autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation | 9 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr 3/4 neut, Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf norm ANC/gr1/2 neut-Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allerg react/hypersens (incl drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis (Clin exam)- Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis (func/sympt)- Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| PTT | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darren Feldman, Assistant Attending | Memorial Sloan Kettering Cancer Center | +1646-422-4491 | Feldmand@mskcc.org |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D010051 | Ovarian Neoplasms |
| D013724 | Teratoma |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D007069 | Ifosfamide |
| D017239 | Paclitaxel |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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|---|---|
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