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Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer

This study has been completed.
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00142415
First received: August 31, 2005
Last updated: February 1, 2017
Last verified: February 2017
Results First Received: November 30, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Metastatic Renal Cell Carcinoma
Interventions: Drug: 111-In-DOTA-cG250
Drug: 177-Lu-DOTA-cG250

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu.

Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu.

Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu.

Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu.

Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu.

Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu.


Participant Flow:   Overall Study
    Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250   Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250   Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250   Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250   Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250   Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250
STARTED   3   3   6   3   3   8 
COMPLETED [1]   3   3   6   3   2   6 
NOT COMPLETED   0   0   0   0   1   2 
Physician Decision                0                0                0                0                1                2 
[1] Defined as completion of Cycle 1 (ie, received 111-In-DOTA-cG250 and 177-Lu-DOTA-cG250)



  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.
The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.

Reporting Groups
  Description
Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu.

Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu.

Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu.

Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu.

Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu.

Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu.

Total Total of all reporting groups

Baseline Measures
   Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250   Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250   Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250   Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250   Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250   Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   6   3   3   8   26 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.7  (8.74)   60.7  (12.86)   64.7  (7.87)   51.3  (6.11)   44.7  (13.80)   58.3  (8.94)   57.8  (10.53) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      2  66.7%      0   0.0%      1  16.7%      0   0.0%      1  33.3%      1  12.5%      5  19.2% 
Male      1  33.3%      3 100.0%      5  83.3%      3 100.0%      2  66.7%      7  87.5%      21  80.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      0   0.0%      3 100.0%      6 100.0%      3 100.0%      3 100.0%      6  75.0%      21  80.8% 
Unknown or Not Reported      3 100.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      2  25.0%      5  19.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      3 100.0%      3 100.0%      6 100.0%      3 100.0%      3 100.0%      8 100.0%      26 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
             
Netherlands   3   3   6   3   3   8   26 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 23.0  (1.29)   28.6  (3.38)   27.2  (4.52)   28.5  (5.84)   31.2  (5.35)   26.7  (1.78)   27.3  (3.95) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Treatment-emergent Adverse Events   [ Time Frame: Up to 1 year ]

2.  Primary:   Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1   [ Time Frame: 12 weeks ]

3.  Primary:   Radiation Absorbed Doses by Organ for 177-Lu-cG250   [ Time Frame: 12 weeks ]

4.  Secondary:   Number of Subjects With Best Overall Tumor Response   [ Time Frame: Up to 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary Macri, Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
phone: (212) 450-1546
e-mail: mmacri@licr.org


Publications of Results:

Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00142415     History of Changes
Other Study ID Numbers: LUD2003-006
Study First Received: August 31, 2005
Results First Received: November 30, 2016
Last Updated: February 1, 2017