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Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (90Y-DOTA-cG250) in Patients With Advanced Renal Cancer

Phase 1
Open (Enrolling)
Renal Cell Carcinoma, Kidney Neoplasm, Renal Cancer, Kidney Cancer

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Trial Information

Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (90Y-DOTA-cG250) in Patients With Advanced Renal Cancer

This is a Phase I dose escalation study using 90Y-DOTA-cG250 for treatment of patients with
advanced kidney carcinoma. The initial group of patients will be treated with 0.2 mCi/Kg of
yttrium-90. Subsequent treatments will be in 0.1 mCi/Kg increments, with the last cohort
increasing by 0.05 mCi/Kg. At least three patients per dose level will be followed for up to
8 weeks (or after recovery from toxicity) with imaging, biochemical, serological, and
hematologic tests for toxicity. CT scans will be carried out at baseline and after 6-8 weeks
(or after recovery from toxicity).

Patients will initially receive 5 mCi/10 mg 111In-DOTA-cG250 antibody (an imaging dose).
Whole body and blood measurements of radioactivity will be obtained on at least three
occasions for one week to determine targeting and dosimetry. Therapeutic 90Y-DOTA-cG250 will
be administered the following week, if there is evidence of In-111 cG250 targeting to
lesions > 2 cm detected on CT. Patients will be treated as outpatients and will receive only
one treatment.

Inclusion Criteria:

- All patients must have histologically proven clear cell renal carcinoma.

- All patients must have a clinical presentation consistent with metastatic renal

- Patients must have bidimensionally measurable disease by conventional imaging methods
including radiography, ultrasound, computer tomography, or other anatomic imaging

- Female patients of childbearing age are required to have a negative pregnancy test
carried out the day of and prior to receiving therapy

- All patients must be ambulatory with a Karnofsky Performance Status of at least 70

Exclusion Criteria:

- Significant prior radiotherapy to the entire pelvis and/or lumbosacral spine.

- Clinically significant cardiac disease

- Serious infection or other serious illness.

- Evidence of CNS tumor involvement.

- Patients known to have hepatobiliary disease and/or HIV/AIDS.

- Pregnancy or breastfeeding.

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

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:

Toxicity defined by NCI Common Toxicity Criteria

Principal Investigator

Robert Motzer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

September 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney Neoplasm
  • Renal Cancer
  • Kidney Cancer
  • antibody
  • renal cell carcinoma
  • advanced renal cancer
  • cG250
  • 90Y
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021