Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250

• Status: Completed
• Trial end date: 2013-03-14
• Target enrollment: 0
• Participant gender: All

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 objectives were to determine the safety, targeting, and dosimetry of ^90Y-DOTA-cG250, using indium-111 conjugated chimeric G250 (^111In-DOTA-cG250) as a surrogate, as well as to evaluate the immunogenicity of cG250.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Collaborator: Memorial Sloan Kettering Cancer Center
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

1. All patients must have had histologically proven clear cell renal carcinoma.

2. Age ≥ 18 years. Children were not enrolled because clear cell renal cancer is rarely seen in children.

3. All patients must have had a clinical presentation consistent with metastatic renal carcinoma.

4. 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.

5. 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.

6. All patients must have been ambulatory with a Karnofsky Performance Status of at least 70.

7. 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

8. Able and willing to give valid written informed consent.

Exclusion Criteria:

1. Significant prior radiotherapy (> 30 Gy) to the entire pelvis and/or lumbosacral spine.

2. Clinically significant cardiac disease (New York Heart Association Class [III/IV]).

3. Serious infection requiring treatment with antibiotics, or other serious illness.

4. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to study agent administration.

5. Survival expectancy of less than 12 weeks.

6. 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.

7. Hypercalcemia > 12.5 mg/100 mL or symptomatic.

8. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.

9. Lack of availability of the patient for clinical and laboratory follow-up assessment.

10. Patients known to have hepatobiliary disease and/or human immunodeficiency virus/acquired immune deficiency syndrome.

11. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.

12. Pregnancy or breastfeeding.

13. Refusal or inability to use effective means of contraception in men or women of childbearing potential.