Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
Kidney Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00003102 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250) (Biological)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- Apr 2000
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
3; 8; 3 | — |
| PRIMARY Number of Patients With Dose-Limiting Toxicities (DLTs) |
0; 1; 3 | — |
| SECONDARY Number of Patients With Best Overall Tumor Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Human Anti-chimeric Antibodies (HACA) |
2; 8; 3; 1; 1; 0 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Histologically proven renal cell carcinoma. Clinical presentation consistent with metastatic renal cell carcinoma. Bidimensionally measurable disease by conventional imaging. Patients must have been off chemotherapy or immunotherapy for at least 6 weeks prior to study entry.
Women of child-bearing age must have had a negative pregnancy test carried out the day of and prior to receiving therapy, and were asked to use effective contraception during the study.
Patients were required to be ambulatory with a Karnofsky Performance Status at least 70, Serum creatinine ≤ 2mg/dl, Serum bilirubin ≤ 1mg/d, White Blood Cells (WBC) ≥ 3,500/mm^3, Platelet count ≥ 100,000/mm^3, Prothrombin time < 1.3 x control.
Exclusion Criteria
Significant prior radiation therapy to the entire pelvis and/or lumbosacral spine.
Clinically significant cardiac disease. Serious infection requiring treatment with antibiotics, or other serious illness.
Women who are pregnant or lactating. Central Nervous System (CNS) tumor involvement. Life expectancy less than 6 weeks. Hypercalcemia greater than 12.5 mg/dL or symptomatic.
Data sourced from ClinicalTrials.gov (NCT00003102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.