Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Wilex
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01582204
First received: April 18, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors. Sometimes, even when a drug is working, it can take several months before the effects are seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called 124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular CT scan.

Research has shown that certain proteins in the blood, called antibodies, can attach themselves to cancer cells without binding to normal cells. In this study, an antibody is used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body, 124I shows up on the PET scan.


Condition Intervention
Renal Cancer
Drug: 124IcG250

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Trial To Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • accuracy of predicting [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]
    The primary endpoint will be the accuracy of predicting response as per 124I-cG250- PET/CT (based on patient SUVs at day 24-29 and at day 39-42, separately) for early detection of best response to sunitinib or pazopanib as per CT imaging in patients with metastatic and/or advanced ccRCC up through 6 cycles of treatment.


Secondary Outcome Measures:
  • progression-free survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Prediction of progression-free survival at 9 months as per CT imaging using SUVmax identified on 124I-cG250-PET/CT (at day 24-29).

  • Detection of metastatic lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Detection of metastatic lesions at baseline (number, anatomical location, size) comparing CT, PET/CT and bone scan:

    1. Number of metastases detected by CT, PET/CT and bone scan in total
    2. Number of metastases detected by CT, PET/CT and bone scan by main metastatic location (local lymph nodes, lung, bone, liver, and other)

  • To evaluate the radiation dosimetry of 124I-cG250. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    using data from patients enrolled in the optional dosimetry sub-study. The data used for this purpose will include PET/CT images, whole-body counts and serum activity measurements. Results will be expressed in terms of absorbed radiation dose per unit administered activity for normal organs.


Estimated Enrollment: 25
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 124IcG250
This is a pilot study of 124I-cG250-PET/CT in 25 evaluable patients with advanced and/or metastatic clear cell renal cell carcinoma (ccRCC) who are scheduled to begin treatment with sunitinib or pazopanib. 124I-cG250-PET/CT will be assessed for its ability to predict response in comparison to standard CT scan of the chest, abdomen, and pelvis.
Drug: 124IcG250
Pts will undergo baseline disease assessment with CT scans (chest, abd & pelvis), 124I-cG250-PET/CT & Tc99mMDP bone scan. W/I 7 days of their lst 124I-cG250 PET/CT, pts will start tx with sunitinib or pazopanib, dosed in successive 6-week cycles. At selected time points during the sunitinib or pazopanib cycle 1, repeat imaging with CT scan & 124I-cG250 PET/CT will be performed. After cycle 2, pts will be followed per standard of care, i.e., pts will have a standard CT scan of the chest, abd, & pelvis with contrast after cycles 2, 3, 4 & 6 (or at the time of disease progression if prior to cycle 6) for determination of best response using RECIST 1.1. Each pt will have 2 124I-cG250-PET/CT scans: baseline & week 4 (during sunitinib or pazopanib tx). All experimental imaging will take place during tx cycle 1. There will be a dosimetry sub-study for pts willing to undergo 3 additional PET/CT scans, whole body counts, & serial blood sampling, following the lst inj of 124I-cG250.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed clear cell carcinoma (conventional) with advanced and/or metastatic disease.
  • Radiographic evidence of unidimensionally measurable disease with at least one lesion ≥2.0 cm in diameter on 16-slice multi-detector CT scan of the chest, abdomen, and pelvis. Lesions will be considered measurable or non- measurable as per definitions provided in RECIST version 1.1
  • Subjects must be planned for treatment with approved treatment doses of sunitinib or pazopanib.
  • Male or female, 18 years of age or older.
  • ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2.
  • Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade ≤2.
  • The following laboratory results should be within the following limits, within 2 weeks prior to study start:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Total serum bilirubin <2.0 mg/dL
  • Platelets ≥100,000/μL
  • Serum creatinine ≤2.0 mg/dL
  • Aspartate aminotransaminase (AST) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)
  • Valid written informed consent signed by the patient prior to any study-specific procedures.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. A negative pregnancy test is required within 24 hours of administration of radiotracer and study initiation for women of childbearing age and potential.
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  • Prior treatment with sunitinib or pazopanib within the past 4 weeks or at any time of greater than 6 weeks duration.
  • Patient is unable to undergo contrast-enhanced CT.
  • Uncontrolled or unstable hyperthyroidism or Grave's Disease.
  • Contraindication to IOSATTM intake (see package insert).
  • Contraindication to sunitinib or pazopanib treatment.
  • Uncontrolled active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months.
  • Unstable cardiac disease, e.g., unstable angina, congestive heart failure or myocardial infarction within the preceding 6 months.
  • Known active hepatitis B/C or HIV (human immunodeficiency virus) infection.
  • Prior exposure to murine proteins or chimeric antibodies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582204

Contacts
Contact: Steven Larson, MD 212-639-7373
Contact: Neeta Pandit-Taskar 212-639-3046

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Steven M. Larson, MD    212-639-7373      
Contact: Neeta Pandit-Taskar, MD    212-639-3046      
Principal Investigator: Steven Larson, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Wilex
Investigators
Principal Investigator: Steven Larson, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01582204     History of Changes
Other Study ID Numbers: 11-134
Study First Received: April 18, 2012
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
clear cell carcinoma
Kidney
MAB-124I-CG250
PET scan
CT scan
sunitinib
pazopanib
11-134

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014