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

NCT02002312 | Completed Phase 2 DMC

• 1 other identifier: CMO2009/322
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

Advanced Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma (ccRCC); Lutetium-177; Lu-177; girentuximab; cG250; Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Evaluation according to RECIST criteria

  12 weeks

Secondary Outcomes (2)

• Progression free survival

  3 years

• Toxicity

  up to 14 weeks after last therapeutic infusion

Study Arms (1)

Lu-177-DOTA-girentuximab

EXPERIMENTAL

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

Interventions

Lu-177-DOTA-girentuximab DRUG

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.

Also known as: Lu-177-DOTA-cG250

Lu-177-DOTA-girentuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

• Muselaers CH, Boers-Sonderen MJ, van Oostenbrugge TJ, Boerman OC, Desar IM, Stillebroer AB, Mulder SF, van Herpen CM, Langenhuijsen JF, Oosterwijk E, Oyen WJ, Mulders PF. Phase 2 Study of Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma. Eur Urol. 2016 May;69(5):767-70. doi: 10.1016/j.eururo.2015.11.033. Epub 2015 Dec 23.

  PMID: 26706103 DERIVED

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: August 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

NL (1)