Phase 2
Completed N=26
Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer
Source: ClinicalTrials.gov NCT00142415 ↗Enrolled (actual)
26
Serious AEs
23.1%
Results posted
Mar 2017
Primary outcomePrimary: Number of Subjects With Treatment-emergent Adverse Events — 3; 3; 6; 3 participants
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 mCi/m^2 of 177-Lu (fixed dose of 10 mg cG250) and escalated in increments of 10 mCi/m^2 of 177-Lu in sequentially enrolled cohorts according to a standard 3 + 3 design until determination of the maximum tolerated dose (MTD). The primary objectives were to determine the safety, targeting, and dosimetry of 177-Lu-DOTA-cG250 in subjects with advanced renal cell carcinoma. The secondary objective was measurement of tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment-emergent Adverse Events |
3; 3; 6; 3; 2; 6 | — |
| PRIMARY Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1 |
0; 0; 1; 0; 2; 1 | — |
| PRIMARY Radiation Absorbed Doses by Organ for 177-Lu-cG250 |
0.24; 1.26; 0.76; 0.44; 0.35; 1.30 | — |
| SECONDARY Number of Subjects With Best Overall Tumor Response |
2; 2; 5; 2; 2; 6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00142415). 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. Informational only — not medical advice.