Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-96126 | |||
| NCI-G97-1136 | |||
| CDR0000065365 | Registry Identifier | NCI PDQ |
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
OBJECTIVES:
OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected.
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4.
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered.
Surgery may be performed after course 2 if indicated.
PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD Chemo and Auto Stem Cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | 5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers. | Until disease progression, up to 5 years. |
| Toxic Effects | Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy | From date of randomization until death of any cause, assessed up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Estimated using the product-limit method of Kaplan and Meier. | Until death from any cause, up to 5 years. |
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sumanta Pal, MD | City of Hope Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HD Chemo and Auto Stem Cells | Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| carboplatin | Drug | AUC=7, daily X 3 |
|
| etoposide | Drug | 20 mg/kg by 2 hours infusion daily X 3 |
|
| ifosfamide | Drug | 3 gm/m2 IV over 30 minutes X 3 days |
|
| paclitaxel | Drug | 425 mg/m2 as 24 hour continuous infusion |
|
| autologous bone marrow transplantation | Procedure | Given in two divided infusions on day -2 and day 0 |
|
| bone marrow ablation with stem cell support | Procedure | Two cycles of high dose chemotherapy followed by stem cell reinfusion |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HD Chemo and Auto Stem Cells | Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Progression-free Survival | Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers. | Posted | Mean | 95% Confidence Interval | Months | Until disease progression, up to 5 years. |
|
|
| ||||||||||||||||||||||||||
| Primary | Toxic Effects | Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy | Posted | Number | participants | From date of randomization until death of any cause, assessed up to 12 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Estimated using the product-limit method of Kaplan and Meier. | Posted | Median | 95% Confidence Interval | Months | Until death from any cause, up to 5 years. |
|
|
Adverse events occurred over a period of 10 years and 6 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HD Chemo and Auto Stem Cells | Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0. | 1 | 48 | 46 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebellar | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Clinical (Physical Exam) | General disorders | COH | Non-systematic Assessment |
| |
| Dysrhythmias | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Fluid Retention | General disorders | COH | Non-systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | COH | Non-systematic Assessment |
| |
| Infection | Infections and infestations | COH | Non-systematic Assessment |
| |
| Ischemia | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Other Misc | General disorders | COH | Non-systematic Assessment |
| |
| Pericardial | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | COH | Non-systematic Assessment |
| |
| Rash/desquamation associated with GVHD for BMT studies | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | COH | Non-systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol. | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Weight (Food Intake) | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Clinical Coagulation | Blood and lymphatic system disorders | COH | Non-systematic Assessment |
| |
| Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Transfusion: Platelets | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| EF/CHF | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Supraventricular and nodal arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Auditory/Ear - Other (Specify, __) | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hearing | Ear and labyrinth disorders | COH | Non-systematic Assessment |
| |
| Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) | Endocrine disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ocular/Visual - Other (Specify, __) | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vision | Eye disorders | COH | Non-systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | COH | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Diarrhea patients with a colostomy | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Incontinence | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Melena/GI bleeding | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Edema | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fever (no infection) | General disorders | COH | Non-systematic Assessment |
| |
| Injection site reaction/extravasation changes | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain - Other (Specify, __) | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rigors/chills | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hepatobiliary/Pancreas - Other (Specify, __) | Hepatobiliary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Allergy | Immune system disorders | COH | Non-systematic Assessment |
| |
| Infection (documented clinically or microbiologically) with ANC <1.0 x 10e9/L | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Infection - Other (Specify, __) | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Infection with unknown ANC | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| AGC | Investigations | COH | Non-systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alkaline Phosphatase | Investigations | COH | Non-systematic Assessment |
| |
| Alkaline phosphatase | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Amylase | Investigations | COH | Non-systematic Assessment |
| |
| Bilirubin | Investigations | COH | Non-systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Creatinine | Investigations | COH | Non-systematic Assessment |
| |
| HGB/HCT | Investigations | COH | Non-systematic Assessment |
| |
| INR (International Normalized Ratio of prothrombin time) | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophils (ANC) (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Partial Thromboplastin Time | Investigations | COH | Non-systematic Assessment |
| |
| Platelets | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Platelets (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| Prothrombin Time | Investigations | COH | Non-systematic Assessment |
| |
| SGOT/SGT | Investigations | COH | Non-systematic Assessment |
| |
| WBC | Investigations | COH | Non-systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cortical/State of Consciousness | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Motor Activity | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral Nervous System Sensory | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Taste alteration (dysgeusia) | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ideation | Psychiatric disorders | COH | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Mood | Psychiatric disorders | COH | Non-systematic Assessment |
| |
| Mood alteration | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | COH | Non-systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | COH | Non-systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, __) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dermatology/Skin - Other (Specify, __) | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Extensive Skin Rash | Skin and subcutaneous tissue disorders | COH | Non-systematic Assessment |
| |
| Local Skin Rash | Skin and subcutaneous tissue disorders | COH | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Acute vascular leak syndrome | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Specify, __) | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | COH | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-359-8111 | 65265 | pfrankel@coh.org |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D010051 | Ovarian Neoplasms |
| D013724 | Teratoma |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| D018239 | Seminoma |
| D018240 | Endodermal Sinus Tumor |
| D018236 | Carcinoma, Embryonal |
| 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 |
| D018237 | Germinoma |
| D008649 | Mesonephroma |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D017239 | Paclitaxel |
| 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 |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
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