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Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer

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ClinicalTrials.gov Identifier: NCT02002312
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with advanced clear cell renal cell carcinoma using RECIST criteria.

Condition or disease Intervention/treatment Phase
Metastatic Clear Cell Renal Cell Carcinoma Drug: Lu-177-DOTA-girentuximab Phase 2

Detailed Description:

This is a Phase II study using Lu-177-DOTA-girentuximab for treatment of patients with advanced clear cell renal cell carcinoma. The trial requires 14 patients. CT scans will be carried out at baseline and after 12 weeks, for response assessment using RECIST criteria.

Patients will initially receive 5 mCi/10 mg Indium-111-DOTA-girentuximab antibody (an imaging dose preceeding Lu-177-girentuximab treatment). Whole body and blood measurements of radioactivity will be obtained on at least three occasions for one week to determine targeting and dosimetry. Only if at least one known and evaluable metastatic lesion is visualized with In-111-DOTA-girentuximab, therapeutic Lu-177-DOTA- girentuximab will be administered the following week. In the absence of disease progression and after recovery from toxicity, patients may be retreated no sooner than 12 weeks after the prior treatment with a dose of no more than 75% of the previous dose, for a total of not more than three treatments. Only patients who have normal pharmacokinetics on the preceding diagnostic In-111-girentuximab study (indicative of human antichimeric antibodies (HACA) negativity) are eligible for retreatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Lutetium-177 Labeled Chimeric Monoclonal Antibody Girentuximab (177Lu-DOTA-girentuximab) in Patients With Advanced Renal Cell Cancer
Study Start Date : August 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Experimental: Lu-177-DOTA-girentuximab
Patients in receive 10 mg of girentuximab coupled to DOTA and labeled with 65 mCi/m2 of Lu-177 if targeting of In-111-DOTA-girentuximab is observed in at least 1 lesion. Patients may be retreated no sooner than 12 weeks after the prior treatment with a dose of no more than 75% of the previous dose, for a total of not more than three treatments.
Drug: Lu-177-DOTA-girentuximab

Drug: In-111-DOTA-girentuximab At day 1, every patient received girentuximab at a dose of 10 mg coupled to DOTA and labeled with 5 mCi of In-111.

Drug: Lu-177-DOTA-girentuximab At day 8-10, every patient receives girentuximab at a dose of 10 mg coupled to DOTA and labeled with 65 mCi/m2 of Lu-177. If eligible, patients are retreated at a dose 75% of the previous dose, for a total of not more than three treatments.

Other Name: Lu-177-DOTA-cG250




Primary Outcome Measures :
  1. Tumor response [ Time Frame: 12 weeks ]
    Evaluation according to RECIST criteria


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 years ]
    Progression free survival is defined as the time measured from the day of first administration of Lu-177-girentuximab to first progression or death, whichever comes first.

  2. Toxicity [ Time Frame: up to 14 weeks after last therapeutic infusion ]
    Toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v3.0)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with proven advanced and progressive RCC of the clear cell type
  • Presence of RECIST v.1.1 evaluable lesions, all < 5 cm
  • Performance status: Karnofsky > 70 %
  • Laboratory values: • White blood cells (WBC) > 3.5 x 109/l • Platelet count > 150 x 109/l • Hemoglobin > 6 mmol/l • Total bilirubin < 2 x upper limit of normal (ULN) • ASAT, ALAT < 3 x ULN (< 5 x ULN if liver metastases present) • MDRD ≥ 40 ml/min
  • Negative pregnancy test for women of childbearing potential (urine or serum)
  • Age over 18 years
  • Written informed consent

Exclusion criteria:

  • Known or suspected CNS metastases including leptomeningeal metastases. History or clinical evidence of (CNS) metastases (unless they are previously-treated CNS metastases and patients meet all 3 of the following criteria: are asymptomatic, have had no evidence of active CNS metastases for ≥3 months prior to enrollment, and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days)
  • Untreated hypercalcemia
  • Chemotherapy, external beam radiation, immunotherapy or angiogenesis inhibitors or mTOR inhibitors within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed , when unirradiated, evaluable lesions elsewhere are present.
  • Cardiac disease with New York Heart Association classification of III or IV
  • Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
  • Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator will significantly affect patients' clinical status
  • Life expectancy shorter than 4 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002312


Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: W. J. Oyen, MD, PhD Department of Nuclear Medicine, Radboud University Medical Center Nijmegen
Principal Investigator: P. F. Mulders, MD, PhD Department of Urology, Radboud University Medical Center Nijmegen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02002312     History of Changes
Other Study ID Numbers: CMO2009/322
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Keywords provided by Radboud University:
Advanced Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma (ccRCC)
Lutetium-177
Lu-177
girentuximab
cG250
Monoclonal Antibody
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs