Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks.

Patients receive placebo IV over 15 minutes once weekly for 24 weeks.

girentuximab

placebo

Pia Kloepfer, MD

Arie Belldegrun, MD, FACS

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer.

PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer.

OBJECTIVES:

Primary

* Evaluate the disease-free and overall survival of patients with primary clear cell renal cell carcinoma at high risk for recurrence treated with chimeric monoclonal antibody cG250 (WX-G250) vs placebo in an adjuvant setting.

Secondary

* Evaluate the safety of these drugs in these patients.
* Assess the quality of life of patients treated with this drug.
* Perform pharmacokinetic analysis of WX-G250.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to risk criteria and participating centers (US vs Non-US). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes once weekly for 24 weeks.
* Arm II: Patients receive placebo IV over 15 minutes once weekly for 24 weeks. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Blood samples are collected for pharmacokinetic analysis.

Quality of life is assessed at baseline, at weeks 12 and 24 during treatment, and then at 6 months after completion of study treatment.

Patients are followed every 3 months during years 1 and 2, every 6 months during years 3 and 4, and then annually during year 5 and thereafter.

PROJECTED ACCRUAL: A total of 864 patients out of the expected 856 (428 per treatment arm) were accrued for this trial.

Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer

A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)

Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.

Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.

Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.

Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).

Heidelberg Pharma AG

Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).

girentuximab: Given IV

Intervention

Patients receive placebo IV over 15 minutes once weekly for 24 weeks.

placebo: Given IV

Placebo

Total

Age, Continuous

Sex: Female, Male

All patients that were enrolled were included in the ITT population used for efficacy analysis; only 855 patients received at least one dose of study treatment and were analyzed for safety (Safety Population, SP)

Head of R&D

All patients that were enrolled were included in the ITT population used for efficacy analysis

Disease-free Survival

Overall Survival

Patients still on study who completed the questionnaire

Quality of Life - Global Health Status

Patients who did sign amendment #3 to the study protocol and received their cG250 infusion as scheduled in the study protocol

Pharmacokinetics of WX-G250

This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.

The CAIX score is determined on the basis of CAIX expression via immunohistochemistry described by a combination of tumor cell extent and staining intensity.

Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.

This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.

Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6

Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex, girentuximab, and WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).

girentuximab: Given IV

Overall Study

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Chelating Agents

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: 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.

Lu-177-DOTA-girentuximab

W. J. Oyen, MD, PhD

P. F. Mulders, MD, PhD

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

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.

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

Phase II Study Of Lutetium-177 Labeled Chimeric Monoclonal Antibody Girentuximab (177Lu-DOTA-girentuximab) in Patients With Advanced Renal Cell Cancer

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.

Toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v3.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer	NCT00087022	Kidney Cancer	girentuximab placebo	18 Years - 120 Years	Heidelberg Pharma AG
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer	NCT00087022	Kidney Cancer	girentuximab placebo	18 Years - 120 Years	Heidelberg Pharma AG
Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer	NCT02002312	Metastatic Clea...	Lu-177-DOTA-gir...	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for girentuximab

Every month we try and update this database with for girentuximab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.