Status:
COMPLETED
Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Renal Cell Carcinoma
Kidney Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This was a Phase 1, open-label, dose-escalation study of yttrium-90 conjugated chimeric G250 (\^90Y-DOTA-cG250) in patients with advanced, measurable clear cell renal cell carcinoma (RCC). Study objec...
Detailed Description
Patients were enrolled sequentially into cohorts of 3 to 6 patients until determination of the maximum tolerated dose (MTD) of \^90Y-DOTA-cG250, defined as the dose level below the dose at which ≥ 2 p...
Eligibility Criteria
Inclusion
- All patients must have had histologically proven clear cell renal carcinoma.
- Age ≥ 18 years. Children were not enrolled because clear cell renal cancer is rarely seen in children.
- All patients must have had a clinical presentation consistent with metastatic renal carcinoma.
- Patients must have had bidimensionally measurable disease by conventional imaging methods including radiography, ultrasound, CT, or other anatomic imaging modalities. Lesions seen on skeletal scintigraphy alone were not considered measurable.
- Female patients of childbearing age were required to have a negative pregnancy test carried out the day of and prior to receiving therapy, and were asked to use effective contraception during the study.
- All patients must have been ambulatory with a Karnofsky Performance Status of at least 70.
- The following laboratory results within the last 2 weeks prior to study Day 1:
- serum creatinine ≤ 2.0 mg/dL
- serum bilirubin (total) ≤ 2.0 mg/dL
- aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
- alanine aminotransferase (ALT) ≤ 2.5 × ULN
- white blood cell (WBC) count ≥ 3500/mm\^3
- platelet count ≥ 100,000/mm\^3
- prothrombin time ≤ 1.3 × control
- Able and willing to give valid written informed consent.
Exclusion
- Significant prior radiotherapy (\> 30 Gy) to the entire pelvis and/or lumbosacral spine.
- Clinically significant cardiac disease (New York Heart Association Class \[III/IV\]).
- Serious infection requiring treatment with antibiotics, or other serious illness.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to study agent administration.
- Survival expectancy of less than 12 weeks.
- Patients with central nervous system (CNS) involvement were excluded under the following criteria:
- Brain metastasis, except for stable disease over 3 months.
- Untreated brain metastasis.
- Evidence of progression of neurologic CNS involvement within 3 months prior to entering the protocol.
- Hypercalcemia \> 12.5 mg/100 mL or symptomatic.
- Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
- Lack of availability of the patient for clinical and laboratory follow-up assessment.
- Patients known to have hepatobiliary disease and/or human immunodeficiency virus/acquired immune deficiency syndrome.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or breastfeeding.
- Refusal or inability to use effective means of contraception in men or women of childbearing potential.
Key Trial Info
Start Date :
July 6 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00199875
Start Date
July 6 2005
End Date
March 14 2013
Last Update
October 10 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021