Status:
COMPLETED
Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This was a Phase I/II, single-center, dose-escalation study. 177-Lutetium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-cG250 (177-Lu-DOTA-cG250) was administered at a starting dose of 30 m...
Detailed Description
Prior to administration of 177-Lu-DOTA-cG250, subjects received 5 mCi/10 mg of the 111-Indium-DOTA-cG250 (111-In-DOTA-cG250) antibody (an imaging dose). Whole body and blood measurements of radioactiv...
Eligibility Criteria
Inclusion
- Subjects with proven advanced and progressive renal cell carcinoma (RCC) of the clear cell type.
- At least one evaluable lesion \< 5 cm.
- Karnofsky performance status ≥ 70%.
- 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
- Negative pregnancy test for women of childbearing potential (urine or serum).
- Age over 18 years.
- Ability to provide written informed consent.
Exclusion
- Known metastases to the brain.
- Untreated hypercalcemia.
- Metastatic disease limited to the bone.
- Pre-exposure to murine/chimeric antibody therapy.
- 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.
- Cardiac disease with New York Heart Association classification of III or IV.
- Subjects who were pregnant, nursing or of reproductive potential and were not practicing an effective method of contraception.
- 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.
- Life expectancy \< 6 months.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00142415
Start Date
February 1 2005
End Date
January 1 2011
Last Update
October 28 2022
Active Locations (1)
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1
University Medical Center Nijmegen
Nijmegen, Netherlands, 6500HB