Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 29 for:    "Teratoma" | "Antineoplastic Agents, Alkylating"

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002931
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 4, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Ovarian Cancer
Teratoma
Testicular Germ Cell Tumor
Interventions Biological: filgrastim
Drug: carboplatin
Drug: etoposide
Drug: ifosfamide
Drug: paclitaxel
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HD Chemo and Auto Stem Cells
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 48
Completed 46
Not Completed 2
Reason Not Completed
rapidly progressing disease during             2
Arm/Group Title HD Chemo and Auto Stem Cells
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants
29
(16 to 49)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
1
   2.1%
Male
47
  97.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title Progression-free Survival
Hide Description 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.
Time Frame Until disease progression, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HD Chemo and Auto Stem Cells
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 48
Mean (95% Confidence Interval)
Unit of Measure: Months
11.8 [1] 
(5.8 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
2.Primary Outcome
Title Toxic Effects
Hide Description Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy
Time Frame From date of randomization until death of any cause, assessed up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HD Chemo and Auto Stem Cells
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: participants
Hyperglycemia 4
Transaminase alone 6
Mucositis/stomatitis 10
Nausea/vomiting 5
Febrile neutropenia 1
Diarrhea 3
Hyperbilirubinemia 3
Fever w/o neutropenia 2
Hypocalcemia 2
Hemorrhage 1
Elevated INR/Prothrombin time 2
Renal Failure 1
Constipation 1
Esophagitis 1
3.Secondary Outcome
Title Overall Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier.
Time Frame Until death from any cause, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HD Chemo and Auto Stem Cells
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 48
Median (95% Confidence Interval)
Unit of Measure: Months
21.7 [1] 
(12.7 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Time Frame Adverse events occurred over a period of 10 years and 6 months.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title HD Chemo and Auto Stem Cells
Hide Arm/Group Description 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.
All-Cause Mortality
HD Chemo and Auto Stem Cells
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HD Chemo and Auto Stem Cells
Affected / at Risk (%) # Events
Total   1/48 (2.08%)    
Renal and urinary disorders   
Renal failure * 1  1/48 (2.08%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HD Chemo and Auto Stem Cells
Affected / at Risk (%) # Events
Total   46/48 (95.83%)    
Blood and lymphatic system disorders   
Clinical Coagulation * 1  10/48 (20.83%)  13
Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) * 2  12/48 (25.00%)  19
Transfusion: Platelets * 2  1/48 (2.08%)  1
Transfusion: pRBCs * 2  1/48 (2.08%)  1
Cardiac disorders   
Dysrhythmias * 1  9/48 (18.75%)  13
Ischemia * 1  9/48 (18.75%)  13
Pericardial * 1  9/48 (18.75%)  13
Cardiac ischemia/infarction * 2  1/48 (2.08%)  1
EF/CHF * 1  9/48 (18.75%)  13
Palpitations * 2  1/48 (2.08%)  1
Supraventricular and nodal arrhythmia * 2  19/48 (39.58%)  25
Ear and labyrinth disorders   
Auditory/Ear - Other (Specify, __) * 2  3/48 (6.25%)  6
Hearing * 1  16/48 (33.33%)  21
Endocrine disorders   
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) * 2  1/48 (2.08%)  1
Eye disorders   
Dry eye syndrome * 2  1/48 (2.08%)  1
Ocular/Visual - Other (Specify, __) * 2  1/48 (2.08%)  4
Ophthalmoplegia/diplopia (double vision) * 2  3/48 (6.25%)  3
Vision * 1  16/48 (33.33%)  22
Vision-blurred vision * 2  1/48 (2.08%)  1
Watery eye (epiphora, tearing) * 2  1/48 (2.08%)  1
Gastrointestinal disorders   
Hematemesis * 2  3/48 (6.25%)  4
Stomatitis * 1  16/48 (33.33%)  25
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol. * 2  1/48 (2.08%)  1
Colitis * 2  1/48 (2.08%)  1
Constipation * 1  28/48 (58.33%)  39
Diarrhea * 2  41/48 (85.42%)  64
Diarrhea patients with a colostomy * 2  2/48 (4.17%)  4
Esophagitis * 3  2/48 (4.17%)  3
Gastritis (including bile reflux gastritis) * 2  1/48 (2.08%)  1
Heartburn/dyspepsia * 2  8/48 (16.67%)  9
Incontinence * 2  2/48 (4.17%)  2
Melena/GI bleeding * 2  3/48 (6.25%)  4
Mucositis/stomatitis (functional/symptomatic) * 2  29/48 (60.42%)  45
Nausea * 2  46/48 (95.83%)  74
Proctitis * 2  2/48 (4.17%)  2
Vomiting * 2  44/48 (91.67%)  73
General disorders   
Clinical (Physical Exam) * 1  13/48 (27.08%)  20
Fluid Retention * 1  16/48 (33.33%)  25
Other Misc * 1  14/48 (29.17%)  57
Edema * 2  15/48 (31.25%)  16
Fatigue (asthenia, lethargy, malaise) * 2  1/48 (2.08%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 2  18/48 (37.50%)  26
Fever (no infection) * 1  15/48 (31.25%)  22
Injection site reaction/extravasation changes * 2  2/48 (4.17%)  2
Pain - Other (Specify, __) * 2  11/48 (22.92%)  13
Rigors/chills * 2  17/48 (35.42%)  25
Hepatobiliary disorders   
Hepatobiliary/Pancreas - Other (Specify, __) * 2  2/48 (4.17%)  2
Immune system disorders   
Allergy * 1  16/48 (33.33%)  25
Infections and infestations   
Infection * 1  16/48 (33.33%)  25
Infection (documented clinically or microbiologically) with ANC <1.0 x 10e9/L * 2  1/48 (2.08%)  1
Infection - Other (Specify, __) * 2  1/48 (2.08%)  1
Infection with unknown ANC * 2  2/48 (4.17%)  2
Infection without neutropenia * 2  3/48 (6.25%)  4
Investigations   
AGC * 1  16/48 (33.33%)  25
ALT, SGPT (serum glutamic pyruvic transaminase) * 2  27/48 (56.25%)  42
AST, SGOT(serum glutamic oxaloacetic transaminase) * 2  27/48 (56.25%)  43
Alkaline Phosphatase * 1  13/48 (27.08%)  20
Alkaline phosphatase * 2  19/48 (39.58%)  24
Amylase * 1  1/48 (2.08%)  1
Bilirubin * 1  13/48 (27.08%)  20
Bilirubin (hyperbilirubinemia) * 2  12/48 (25.00%)  15
Creatinine * 1  26/48 (54.17%)  36
HGB/HCT * 1  4/48 (8.33%)  5
INR (International Normalized Ratio of prothrombin time) * 2  24/48 (50.00%)  38
Neutrophils (ANC) (Somlo COH) * 4  7/48 (14.58%)  11
Neutrophils/granulocytes (ANC/AGC) * 2  23/48 (47.92%)  39
PTT (Partial Thromboplastin Time) * 2  16/48 (33.33%)  23
Partial Thromboplastin Time * 1  10/48 (20.83%)  13
Platelets * 2  38/48 (79.17%)  61
Platelets (Somlo COH) * 4  7/48 (14.58%)  11
Prothrombin Time * 1  10/48 (20.83%)  13
SGOT/SGT * 1  13/48 (27.08%)  20
WBC * 1  5/48 (10.42%)  7
Metabolism and nutrition disorders   
Weight (Food Intake) * 1  7/48 (14.58%)  12
Albumin, serum-low (hypoalbuminemia) * 2  3/48 (6.25%)  5
Anorexia * 2  13/48 (27.08%)  16
Calcium, serum-high (hypercalcemia) * 2  3/48 (6.25%)  3
Calcium, serum-low (hypocalcemia) * 2  29/48 (60.42%)  42
Glucose, serum-high (hyperglycemia) * 2  30/48 (62.50%)  46
Glucose, serum-low (hypoglycemia) * 3  2/48 (4.17%)  2
Hypercalcemia * 1  14/48 (29.17%)  21
Hyperglycemia * 1  15/48 (31.25%)  22
Hypocalcemia * 1  14/48 (29.17%)  21
Hypoglycemia * 1  15/48 (31.25%)  22
Hypomagnesemia * 1  15/48 (31.25%)  22
Magnesium, serum-low (hypomagnesemia) * 2  26/48 (54.17%)  39
Phosphate, serum-low (hypophosphatemia) * 2  2/48 (4.17%)  3
Potassium, serum-low (hypokalemia) * 2  2/48 (4.17%)  2
Sodium, serum-low (hyponatremia) * 2  1/48 (2.08%)  2
Nervous system disorders   
Cerebellar * 1  15/48 (31.25%)  21
Cortical/State of Consciousness * 1  16/48 (33.33%)  22
Dizziness * 2  8/48 (16.67%)  9
Extrapyramidal/involuntary movement/restlessness * 2  4/48 (8.33%)  4
Headache * 1  16/48 (33.33%)  22
Motor Activity * 1  15/48 (31.25%)  21
Neuropathy: motor * 2  19/48 (39.58%)  24
Neuropathy: sensory * 2  25/48 (52.08%)  37
Peripheral Nervous System Sensory * 1  15/48 (31.25%)  21
Seizure * 2  1/48 (2.08%)  1
Somnolence/depressed level of consciousness * 2  6/48 (12.50%)  6
Speech impairment (e.g., dysphasia or aphasia) * 2  1/48 (2.08%)  1
Syncope (fainting) * 2  1/48 (2.08%)  1
Taste alteration (dysgeusia) * 2  5/48 (10.42%)  5
Psychiatric disorders   
Confusion * 2  1/48 (2.08%)  1
Hallucinations * 2  3/48 (6.25%)  3
Ideation * 1  16/48 (33.33%)  22
Insomnia * 2  16/48 (33.33%)  21
Mood * 1  16/48 (33.33%)  22
Mood alteration * 2  18/48 (37.50%)  21
Renal and urinary disorders   
Hematuria * 1  10/48 (20.83%)  15
Hematuria (in the absence of vaginal bleeding) * 2  5/48 (10.42%)  6
Pain * 2  22/48 (45.83%)  72
Proteinuria * 1  11/48 (22.92%)  16
Urinary retention (including neurogenic bladder) * 3  1/48 (2.08%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary * 1  16/48 (33.33%)  25
Adult Respiratory Distress Syndrome (ARDS) * 2  2/48 (4.17%)  2
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) * 2  1/48 (2.08%)  1
Cough * 2  7/48 (14.58%)  7
Dyspnea (shortness of breath) * 2  5/48 (10.42%)  5
Hemoptysis * 2  3/48 (6.25%)  3
Hemorrhage, pulmonary/upper respiratory * 2  7/48 (14.58%)  7
Hiccoughs (hiccups, singultus) * 2  11/48 (22.92%)  16
Pulmonary/Upper Respiratory - Other (Specify, __) * 2  2/48 (4.17%)  2
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) * 2  2/48 (4.17%)  2
Skin and subcutaneous tissue disorders   
Rash/desquamation associated with GVHD for BMT studies * 2  4/48 (8.33%)  5
Dermatology/Skin - Other (Specify, __) * 2  10/48 (20.83%)  15
Extensive Skin Rash * 1  13/48 (27.08%)  19
Local Skin Rash * 1  13/48 (27.08%)  19
Rash/desquamation * 3  17/48 (35.42%)  24
Sweating (diaphoresis) * 2  2/48 (4.17%)  2
Vascular disorders   
Hemorrhage * 1  16/48 (33.33%)  25
Acute vascular leak syndrome * 2  1/48 (2.08%)  1
Flushing * 2  1/48 (2.08%)  1
Hemorrhage/Bleeding - Other (Specify, __) * 2  9/48 (18.75%)  11
Hypertension * 1  13/48 (27.08%)  17
Hypotension * 2  19/48 (39.58%)  23
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COH
2
Term from vocabulary, meddra9.0
3
Term from vocabulary, meddra10.0
4
Term from vocabulary, Somlo
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-359-8111 ext 65265
EMail: pfrankel@coh.org
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00002931     History of Changes
Other Study ID Numbers: 96126
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-96126
NCI-G97-1136
CDR0000065365 ( Registry Identifier: NCI PDQ )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: November 4, 2016
Results First Posted: January 4, 2017
Last Update Posted: February 23, 2017