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Sponsors and Collaborators: |
Ludwig Institute for Cancer Research Radboud University |
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Information provided by: | Ludwig Institute for Cancer Research |
ClinicalTrials.gov Identifier: | NCT00142415 |
The purpose of this study is to determine whether 177Lu-DOTA-cG250 is effective for treatment of patients with advanced renal cell carcinoma
Condition | Intervention | Phase |
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Advanced Renal Cell Carcinoma |
Drug: cG250-In111 Drug: cG250-Lu177 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Increasing Doses of Lutetium-177 Labeled Chimeric Monoclonal Antibody cG250 in Patients With Advanced Renal Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
This is a Phase I/II dose escalation study using 177Lu-DOTA-cG250 for treatment of patients with advanced renal cell carcinoma. The trial requires a minimum of 6 patients and a maximum of 18 patients. The initial group of patients will be treated with 30 mCi/m2 of Lu-177. Subsequent treatments will be in 10 mCi/m2 increments. At least three patients per dose level will be followed for up to 12 weeks with imaging, biochemical and hematologic tests to determine the safety of 177Lu-DOTA-cG250. CT scans will be carried out at baseline and after 12 weeks (or after recovery from toxicity), for response assessment.
Patients will initially receive 5 mCi/10 mg 111In-DOTA-cG250 antibody (an imaging dose preceeding Lu-177-cG250 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-cG250, therapeutic 177Lu-DOTA-cG250 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-cG250 study (indicative of HACA negativity) are eligible for retreatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values obtained less than 14 days prior to registration:• White blood cells (WBC) > 3.5 x 109/l
Exclusion Criteria:
Contact: W.J.G. Oyen, MD | +31(24)3614048 | w.oyen@nucmed.umcn.nl |
Contact: B.W. Hendrickx, MD | +31(24)3614048 | b.hendrickx@nucmed.umcn.nl |
Netherlands, Gelderland | |
University Medical Center Nijmegen | Recruiting |
Nijmegen, Gelderland, Netherlands, 6500HB | |
Contact: W.J.G. Oyen, MD, PhD +31(24)3614048 w.oyen@nucmed.umcn.nl | |
Principal Investigator: W.J.G. Oyen, MD | |
Principal Investigator: P.F.A. Mulders, MD | |
Sub-Investigator: O.C. Boerman, PhD | |
Sub-Investigator: E. Oosterwijk, PhD | |
Sub-Investigator: F.H.M. Corstens, MD | |
Sub-Investigator: P.H.M. de Mulder, MD | |
Sub-Investigator: B.W. Hendrickx, MD |
Principal Investigator: | W.J.G. Oyen, MD, PhD | Department of Nuclear Medicine, University Medical Center Nijmegen |
Principal Investigator: | P.F.A. Mulders, MD, PhD | Department of Urology, University Medical Center Nijmegen |
Responsible Party: | Ludwig Institute for Cancer Research ( Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs ) |
Study ID Numbers: | LUD2003-006 |
Study First Received: | August 31, 2005 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00142415 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Advanced Renal cell carcinoma Lutetium-177 cG250 Monoclonal Antibody |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Antibodies, Monoclonal Antibodies Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Immunoglobulins Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |