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Phase I/II Study of Increasing Doses of Lutetium-177 Labeled Chimeric Monoclonal Antibody cG250 in Patients With Advanced Renal Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Advanced Renal Cell Carcinoma

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Trial Information

Phase I/II Study of Increasing Doses of Lutetium-177 Labeled Chimeric Monoclonal Antibody cG250 in Patients With Advanced Renal Cancer

This is a Phase I/II dose escalation study using 177Lu-DOTA-cG250 for treatment of patients
with advanced renal cell carcinoma. The trial requires a minimum of 6 patients and a maximum
of 18 patients. The initial group of patients will be treated with 30 mCi/m2 of Lu-177.
Subsequent treatments will be in 10 mCi/m2 increments. At least three patients per dose
level will be followed for up to 12 weeks with imaging, biochemical and hematologic tests to
determine the safety of 177Lu-DOTA-cG250. CT scans will be carried out at baseline and
after 12 weeks (or after recovery from toxicity), for response assessment.

Patients will initially receive 5 mCi/10 mg 111In-DOTA-cG250 antibody (an imaging dose
preceeding Lu-177-cG250 treatment). Whole body and blood measurements of radioactivity will
be obtained on at least three occasions for one week to determine targeting and dosimetry.
Only if at least one known and evaluable metastatic lesion is visualized with In-111-cG250,
therapeutic 177Lu-DOTA-cG250 will be administered the following week. In the absence of
disease progression and after recovery from toxicity, patients may be retreated no sooner
than 12 weeks after the prior treatment with a dose of no more than 75% of the previous
dose, for a total of not more than three treatments. Only patients who have normal
pharmacokinetics on the preceding diagnostic In-111-cG250 study (indicative of HACA
negativity) are eligible for retreatment.

Inclusion Criteria:

1. Patients with proven advanced and progressive renal cell carcinoma of the clear cell

2. At least one evaluable lesion less than 5 cm

3. Performance status: Karnofsky > 70 %

4. Laboratory values obtained less than 14 days prior to registration:• White blood
cells (WBC) > 3.5 x 109/l

- Platelet count > 100 x 109/l

- Hemoglobin > 6 mmol/l

- Total bilirubin < 2 x upper limit of normal (ULN)

- ASAT, ALAT < 3 x ULN (< 5 x ULN if liver metastases present)

- Serum creatinine < 2 x ULN

5. Negative pregnancy test for women of childbearing potential (urine or serum)

6. Age over 18 years

7. Ability to provide written informed consent

Exclusion Criteria:

1. Known metastases to the brain

2. Untreated hypercalcemia

3. Metastatic disease limited to the bone

4. Pre-exposure to murine/chimeric antibody therapy

5. Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study.
Limited field external beam radiotherapy to prevent pathological fractures is
allowed, when unirradiated, evaluable lesions elsewhere are present.

6. Cardiac disease with New York Heart Association classification of III or IV

7. Patients who are pregnant, nursing or of reproductive potential and are not
practicing an effective method of contraception

8. Any unrelated illness, e.g. active infection, inflammation, medical condition or
laboratory abnormalities, which in the judgement of the investigator will
significantly affect patients' clinical status

9. Life expectancy shorter than 6 months.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of increasing doses of 177Lu-DOTA-cG250 in patients with advanced renal cancer to establish the MTD

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

W.J.G. Oyen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Nuclear Medicine, University Medical Center Nijmegen


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

February 2005

Completion Date:

April 2013

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • Advanced Renal cell carcinoma
  • Lutetium-177
  • cG250
  • Monoclonal Antibody
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms