Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer
NCT ID: NCT00142415
Last Updated: 2022-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2005-02-28
2011-01-31
Brief Summary
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Detailed Description
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Subjects in the initial cohort were enrolled sequentially to receive 30 mCi/m\^2 of 177-Lu-DOTA-cG250 (fixed dose of 10 mg cG250). In the absence of a dose-limiting toxicity, the dose was escalated in each subsequent cohort in 10 mCi/m\^2 increments of 177-Lu. At least 3 subjects per dose level were followed for up to 12 weeks with imaging, biochemical, and hematologic tests. Safety was monitored continuously throughout the study.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250
Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m\^2 of 177-Lu.
111-In-DOTA-cG250
On Day 1, each subject received a single intravenous (IV) infusion 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, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.
Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250
Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m\^2 of 177-Lu.
111-In-DOTA-cG250
On Day 1, each subject received a single intravenous (IV) infusion 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, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.
Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250
Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m\^2 of 177-Lu.
111-In-DOTA-cG250
On Day 1, each subject received a single intravenous (IV) infusion 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, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.
Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250
Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m\^2 of 177-Lu.
111-In-DOTA-cG250
On Day 1, each subject received a single intravenous (IV) infusion 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, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.
Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250
Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m\^2 of 177-Lu.
111-In-DOTA-cG250
On Day 1, each subject received a single intravenous (IV) infusion 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, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.
Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250
Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m\^2 of 177-Lu.
111-In-DOTA-cG250
On Day 1, each subject received a single intravenous (IV) infusion 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, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.
Interventions
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111-In-DOTA-cG250
On Day 1, each subject received a single intravenous (IV) infusion 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, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one evaluable lesion \< 5 cm.
3. Karnofsky performance status ≥ 70%.
4. Laboratory values obtained \< 14 days prior to registration:
* White blood cells (WBC) ≥ 3.5 × 10\^9/L
* Platelet count ≥ 100 × 10\^9/L
* Hemoglobin ≥ 6 mmol/L
* Total bilirubin ≤ 2 × upper limit of normal (ULN)
* Aspartate aminotransferase and alanine aminotransferase ≤ 3 × ULN (\< 5 × ULN if liver metastases present)
* Serum creatinine ≤ 2 × ULN
5. Negative pregnancy test for women of childbearing potential (urine or serum).
6. Age over 18 years.
7. Ability to provide written informed consent.
Exclusion Criteria
2. Untreated hypercalcemia.
3. Metastatic disease limited to the bone.
4. Pre-exposure to murine/chimeric antibody therapy.
5. Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures was allowed, when unirradiated, evaluable lesions were present elsewhere.
6. Cardiac disease with New York Heart Association classification of III or IV.
7. Subjects who were pregnant, nursing or of reproductive potential and were not practicing an effective method of contraception.
8. Any unrelated illness, e.g., active infection, inflammation, medical condition or laboratory abnormality, that in the judgement of the investigator would have significantly affected the subject's clinical status.
9. Life expectancy \< 6 months.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Ludwig Institute for Cancer Research
OTHER
Responsible Party
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Principal Investigators
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W.J.G. Oyen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nuclear Medicine, University Medical Center Nijmegen
P.F.A. Mulders, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, University Medical Center Nijmegen
Locations
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University Medical Center Nijmegen
Nijmegen, , Netherlands
Countries
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References
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Stillebroer AB, Boerman OC, Desar IM, Boers-Sonderen MJ, van Herpen CM, Langenhuijsen JF, Smith-Jones PM, Oosterwijk E, Oyen WJ, Mulders PF. Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma. Eur Urol. 2013 Sep;64(3):478-85. doi: 10.1016/j.eururo.2012.08.024. Epub 2012 Aug 21.
Stillebroer AB, Zegers CM, Boerman OC, Oosterwijk E, Mulders PF, O'Donoghue JA, Visser EP, Oyen WJ. Dosimetric analysis of 177Lu-cG250 radioimmunotherapy in renal cell carcinoma patients: correlation with myelotoxicity and pretherapeutic absorbed dose predictions based on 111In-cG250 imaging. J Nucl Med. 2012 Jan;53(1):82-9. doi: 10.2967/jnumed.111.094896. Epub 2011 Dec 12.
Related Links
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Stillebroer et al. J Nucl Med 2012; 53(1):82-89
Other Identifiers
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LUD2003-006
Identifier Type: -
Identifier Source: org_study_id
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