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Trial record 86 of 430 for:    ifosfamide

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma

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ClinicalTrials.gov Identifier: NCT00002601
Recruitment Status : Completed
First Posted : March 11, 2004
Results First Posted : January 19, 2017
Last Update Posted : March 3, 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
Condition Sarcoma
Interventions Biological: filgrastim
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: melphalan
Procedure: peripheral blood stem cell transplantation
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
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Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.

Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
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Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.

Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
31
(21 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
3
  23.1%
Male
10
  76.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Number of Participants With Grade 3 Bilirubin
Hide Description Criteria for early termination of this feasibility study: > 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; > 2 patients experience grade 3 hepatic or gastrointestinal toxicity or > 3 patients are unable to receive the second cycle of treatment; > 2 patients experience grade 5 toxicity related to treatment regimen.
Time Frame 2 years after completion of treatment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
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Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.

Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants with Grade 3 Bilirubin
3
2.Primary Outcome
Title Toxicities Counts
Hide Description Number of patients with grade 3 and 4 toxicities observed during cycles 1 & 2 using the Common Toxicity Criteria Version for Chemotherapy.
Time Frame 2 months after completion of second cycle of treatment.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cycle 1 Cycle 2
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Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
Overall Number of Participants Analyzed 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia
8
  61.5%
3
  23.1%
Leukopenia
13
 100.0%
11
  84.6%
Neutropenia
13
 100.0%
11
  84.6%
Febrile neutropenia
13
 100.0%
9
  69.2%
Thrombocytopenia
13
 100.0%
11
  84.6%
Mucositis
13
 100.0%
1
   7.7%
Bacteremia/sepsis
2
  15.4%
4
  30.8%
Hyperglycemia
5
  38.5%
1
   7.7%
Pulmonary function impairment (FEV1)
1
   7.7%
0
   0.0%
Pulmonary infiltrates
0
   0.0%
2
  15.4%
Diarrhea
1
   7.7%
0
   0.0%
Arrhythmia
1
   7.7%
1
   7.7%
Hematuria
1
   7.7%
0
   0.0%
Mood
1
   7.7%
1
   7.7%
Elevated PTT
1
   7.7%
0
   0.0%
3.Secondary Outcome
Title 5-year Progression-free Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 25% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.
Time Frame Until disease progression, up to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
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Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.

Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused

Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23
(0 to 46)
4.Secondary Outcome
Title 5-year 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 Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
Hide Arm/Group Description:

Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.

Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused

Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31
(14 to 70)
Time Frame Adverse events collected over a period of 45 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 Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
Hide Arm/Group Description

Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.

Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused

All-Cause Mortality
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Cardiac disorders   
Dysrhythmias * 1  1/13 (7.69%)  1
Investigations   
Partial Thromboplastin Time * 1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary * 1  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COH
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Clinical Coagulation * 1  9/13 (69.23%)  13
Febrile neutropenia * 2  1/13 (7.69%)  2
Cardiac disorders   
Dysrhythmias * 1  6/13 (46.15%)  8
Pericardial * 1  7/13 (53.85%)  10
EF/CHF * 1  6/13 (46.15%)  9
Ear and labyrinth disorders   
Ear disorder * 2  1/13 (7.69%)  1
Hearing * 1  9/13 (69.23%)  16
Eye disorders   
Eye disorder * 2  1/13 (7.69%)  1
Vision * 1  9/13 (69.23%)  16
Gastrointestinal disorders   
Constipation * 1  12/13 (92.31%)  21
Diarrhea * 2  13/13 (100.00%)  22
Mucositis oral * 2  1/13 (7.69%)  1
Nausea * 2  13/13 (100.00%)  23
Vomiting * 2  13/13 (100.00%)  22
General disorders   
Clinical (Physical Exam) * 1  9/13 (69.23%)  12
Hemorrhage * 1  12/13 (92.31%)  21
Other Misc * 1  9/13 (69.23%)  31
Stomatitis * 1  12/13 (92.31%)  22
Chills * 2  1/13 (7.69%)  1
Fatigue * 1  6/13 (46.15%)  10
Fever (no infection) * 1  11/13 (84.62%)  18
Immune system disorders   
Allergy * 1  12/13 (92.31%)  21
Infections and infestations   
Infection * 1  12/13 (92.31%)  21
Investigations   
AGC * 1  12/13 (92.31%)  22
Alanine aminotransferase increased * 2  1/13 (7.69%)  2
Alkaline Phosphatase * 1  9/13 (69.23%)  12
Amylase * 1  4/13 (30.77%)  6
Aspartate aminotransferase increased * 2  1/13 (7.69%)  2
Bilirubin * 1  9/13 (69.23%)  12
Creatinine * 1  7/13 (53.85%)  8
Creatinine increased * 2  1/13 (7.69%)  1
Fibrinogen * 1  2/13 (15.38%)  3
Hyperbilirubinemia * 2  1/13 (7.69%)  1
Neutrophil count decreased * 2  1/13 (7.69%)  2
Partial Thromboplastin Time * 1  7/13 (53.85%)  11
Platelet count decreased * 2  1/13 (7.69%)  2
Platelets * 1  12/13 (92.31%)  22
Prothrombin Time * 1  9/13 (69.23%)  13
SGOT/SGT * 1  9/13 (69.23%)  12
WBC * 1  1/13 (7.69%)  2
Metabolism and nutrition disorders   
Weight (Food Intake) * 1  8/13 (61.54%)  12
Anorexia * 2  1/13 (7.69%)  2
Hypercalcemia * 1  12/13 (92.31%)  21
Hyperglycemia * 2  13/13 (100.00%)  23
Hypocalcemia * 2  13/13 (100.00%)  23
Hypoglycemia * 1  12/13 (92.31%)  21
Hypomagnesemia * 2  13/13 (100.00%)  23
Nervous system disorders   
Cerebellar * 1  9/13 (69.23%)  16
Cortical/State of Consciousness * 1  9/13 (69.23%)  16
Dizziness * 2  1/13 (7.69%)  2
Headache * 2  10/13 (76.92%)  18
Motor Activity * 1  9/13 (69.23%)  16
Peripheral Nervous System Sensory * 1  9/13 (69.23%)  16
Peripheral motor neuropathy * 2  1/13 (7.69%)  1
Peripheral sensory neuropathy * 2  1/13 (7.69%)  1
Taste alteration * 2  1/13 (7.69%)  1
Psychiatric disorders   
Depression * 2  1/13 (7.69%)  1
Ideation * 1  7/13 (53.85%)  12
Insomnia * 2  1/13 (7.69%)  1
Mood * 1  9/13 (69.23%)  16
Renal and urinary disorders   
Fluid Retention * 1  12/13 (92.31%)  20
Hematuria * 1  7/13 (53.85%)  8
Proteinuria * 1  7/13 (53.85%)  8
Respiratory, thoracic and mediastinal disorders   
Pulmonary * 1  11/13 (84.62%)  18
Hiccough * 2  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
Alopecia * 1  5/13 (38.46%)  8
Extensive Skin Rash * 1  8/13 (61.54%)  11
Local Skin Rash * 1  8/13 (61.54%)  11
Vascular disorders   
Ischemia * 1  7/13 (53.85%)  10
Hypertension * 1  2/13 (15.38%)  3
Hypotension * 1  2/13 (15.38%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COH
2
Term from vocabulary, meddra9.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: (626)256-4673 ext 65265
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00002601     History of Changes
Other Study ID Numbers: 94072
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-IRB-94072 ( Registry Identifier: NCI PDQ )
NCI-V94-0545
CDR0000063845 ( Registry Identifier: NCI PDQ )
First Submitted: November 1, 1999
First Posted: March 11, 2004
Results First Submitted: November 21, 2016
Results First Posted: January 19, 2017
Last Update Posted: March 3, 2017