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Trial record 10 of 164 for:    ovarian cancer and Minnesota

Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers

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: NCT00319748
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : September 25, 2009
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by:
Masonic Cancer Center, University of Minnesota

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Intervention: Drug: 852A

  Participant Flow

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
15 patients were originally consented to enter the study; however 1 patient died before participating in study and 1 patient made the decision to withdraw before being treated.

Reporting Groups
  Description
Patients Treated With 852A Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).

Participant Flow:   Overall Study
    Patients Treated With 852A
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  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
Patients Treated With 852A Study Drug Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).

Baseline Measures
   Patients Treated With 852A Study Drug 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 52 
 (24 to 63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

1.  Primary:   Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.   [ Time Frame: after 12 weeks (24 doses of 852A) ]

2.  Secondary:   Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)   [ Time Frame: Prior to Dose 1 and 6 hours after Dose 1 ]

3.  Secondary:   Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)   [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ]

4.  Secondary:   Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)   [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ]

5.  Secondary:   Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)   [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ]

6.  Secondary:   Mean Difference Values for Soluble CD40 Ligand (sCD40L)   [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ]

7.  Secondary:   Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)   [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ]


  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
Other Adverse Events that occurred were noted as targeted toxicities and not captured as adverse events.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Melissa Geller, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-3111
e-mail: gelle005@umn.edu



Responsible Party: Melissa Geller, M.D., Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00319748     History of Changes
Obsolete Identifiers: NCT00363493
Other Study ID Numbers: 06US03IMP-852A
MT2006-02 ( Other Identifier: Blood and Bone Marrow Transplantation Program )
2006LS005 ( Other Identifier: Masonic Cancer Center, University of Minnesota )
First Submitted: April 27, 2006
First Posted: April 27, 2006
Results First Submitted: August 17, 2009
Results First Posted: September 25, 2009
Last Update Posted: December 28, 2017