Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00423852
First received: January 16, 2007
Last updated: April 12, 2016
Last verified: April 2016
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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: ifosfamide
Drug: paclitaxel
Procedure: autologous hematopoietic stem cell transplantation
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
No text entered.

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
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


Participant Flow:   Overall Study
    Chemotherapy With Stem Cell Support  
STARTED     26  
COMPLETED     23  
NOT COMPLETED     3  
Removed pior to the high-dose portion                 3  



  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
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


Baseline Measures
    Chemotherapy With Stem Cell Support  
Number of Participants  
[units: participants]
  26  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     25  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     25  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures
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1.  Primary:   Response   [ Time Frame: 2 year ]

2.  Primary:   Maximum Tolerated Dose of Ifosfamide   [ Time Frame: 4 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: Dr. Darren Feldman, Assistant Attending
Organization: Memorial Sloan Kettering Cancer Center
phone: +1646-422-4491
e-mail: Feldmand@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00423852     History of Changes
Other Study ID Numbers: 06-077
MSKCC-06077
Study First Received: January 16, 2007
Results First Received: December 17, 2015
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board