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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00002601
First received: November 1, 1999
Last updated: November 21, 2016
Last verified: November 2016
Results First Received: November 21, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT

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


Participant Flow:   Overall Study
    Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT

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


Baseline Measures
   Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Median (Full Range)
 31 
 (21 to 41) 
Gender 
[Units: Participants]
Count of Participants
 
Female      3  23.1% 
Male      10  76.9% 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Evaluate the Feasibility of Administration of Two Cycles of High-dose Chemotherapy Followed by Autologous Stem Cell Support in Patients With High-risk or Advanced Sarcomas.   [ Time Frame: 2 years after completion of treatment ]

2.  Primary:   Evaluate the Toxicities of Two Cycles of Sequential High-dose Chemotherapy With Autologous Stem Cell Support.   [ Time Frame: 2 months after completion of second cycle of treatment. ]

3.  Secondary:   5-year Progression-free Survival   [ Time Frame: Until disease progression, up to 5 Years ]

4.  Secondary:   5-year Overall Survival   [ Time Frame: Until death from any cause, up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: pfrankel@och.org



Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00002601     History of Changes
Other Study ID Numbers: 94072
P30CA033572 ( US NIH Grant/Contract Award Number )
CHNMC-IRB-94072 ( Registry Identifier: NCI PDQ )
NCI-V94-0545
CDR0000063845 ( Registry Identifier: NCI PDQ )
Study First Received: November 1, 1999
Results First Received: November 21, 2016
Last Updated: November 21, 2016