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Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma

NCT00520533 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-10-12

Study results available
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Summary

This clinical trial explores the safety, efficacy, and effects on functional imaging of cG250 monoclonal antibody (mAb) administered intravenously weekly in combination with daily oral sunitinib, in patients with advanced renal cell carcinoma.

Conditions

  • Renal Cell Carcinoma (RCC)

Interventions

BIOLOGICAL

Chimeric monoclonal antibody cG250

First Cycle: cG250 10 mg/m² intravenous infusion, weekly for five weeks, followed by a two-week break. 1st \& 5th dose will be trace-labeled with a radioactive substance detectable on a PET scanner (124I-cG250). Second cycle (investigator discretion): cG250 10 mg/m² intravenous infusion, weekly for four weeks followed by a two-week break. No 124I-cG250 will be used in the 2nd cycle. Up to 2 cycles available.

DRUG

Sunitinib malate

First Cycle: Sunitinib 50 mg orally daily for 4 weeks (starts 8th day of 1st treatment cycle), followed by a two-week period off sunitinib. Second cycle (investigator discretion): Sunitinib 50 mg orally daily for 4 weeks (starts on 1st day of 2nd treatment cycle), followed by a two-week period off sunitinib. Up to 2 cycles available on-study.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Heidelberg Pharma AG

    collaborator INDUSTRY

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • A/Prof Ian D Davis, FRACP, FAChPM, MBBS, PhD · Ludwig Institute for Cancer Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-07-31
Completion
2012-09-30

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520533 on ClinicalTrials.gov