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Trial record 4 of 4 for:    7800006 [PUBMED-IDS]

A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas

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ClinicalTrials.gov Identifier: NCT00001566
Recruitment Status : Completed
First Posted : November 4, 1999
Results First Posted : June 12, 2012
Last Update Posted : June 15, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ewing's Sarcoma
Rhabdomyosarcoma
Interventions: Biological: therapeutic autologous dendritic cells
Drug: indinavir sulfate
Procedure: peripheral blood stem cell transplantation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
42 patients were enrolled in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.

Participant Flow:   Overall Study
    Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
STARTED   42 
Completed Immunotherapy   23 
COMPLETED   23 
NOT COMPLETED   19 
patients' choice to discontinue protocol                3 
stopped after C3 due to symptomatic PD                1 
Death                13 
Lost to Follow-up                1 
unable to complete initial apheresis                1 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.

Baseline Measures
   Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Participants]
 
<=18 years   26 
Between 18 and 65 years   16 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 18.67  (8.59) 
Gender 
[Units: Participants]
 
Female   17 
Male   25 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   2 
Not Hispanic or Latino   40 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   42 


  Outcome Measures

1.  Primary:   Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution   [ Time Frame: 20 weeks post vaccination ]

2.  Primary:   The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy   [ Time Frame: 2 to 6 months ]

3.  Primary:   Number of Participants With an Immune Response to the Translocation Breakpoint Peptide   [ Time Frame: 5 years ]

4.  Primary:   Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7   [ Time Frame: 5 years ]

5.  Primary:   Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation   [ Time Frame: Once per enrollment ]

6.  Secondary:   Percentage of Participants Overall Survival   [ Time Frame: 5 years ]

7.  Secondary:   Percent of Participants: Event Free Survival   [ Time Frame: 5 years ]

8.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 5 years ]

9.  Secondary:   Median Overall Survival   [ Time Frame: 5.4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Crystal Mackall, M.D.
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
phone: 301-402-5940
e-mail: mackallc@mail.nih.gov


Publications of Results:
Other Publications:

Responsible Party: Crystal L. Mackall, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00001566     History of Changes
Obsolete Identifiers: NCT00019266
Other Study ID Numbers: 970052
97-C-0052
First Submitted: November 3, 1999
First Posted: November 4, 1999
Results First Submitted: March 28, 2012
Results First Posted: June 12, 2012
Last Update Posted: June 15, 2012