REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT

NCT01762592 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: WX/20-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate cT1-renal masses.

Conditions

Renal Cell Carcinoma; Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of Iodine (124I) Girentuximab PET/CT scans will be compared to the threshold value of 0.70 using a two-sided exact binomial test at level 0.05.

  PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion.

Study Arms (1)

Iodine (124I) Girentuximab

EXPERIMENTAL

Single infusion of radio labeled antibody: 30 mL will be infused using an infusion pump at a rate of 2mL/min over 15 minutes on study day 0.

Drug: Iodine (124I) Girentuximab

Interventions

Iodine (124I) Girentuximab DRUG

i.v.

Also known as: 124I-cG250

Iodine (124I) Girentuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age.
• Presence of indeterminate cT1 renal mass by screening CT with and without contrast or MRI with and without contrast (MRI only if CT is contra-indicated).
• Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
• Recovered from toxicity of any prior therapy to grade 1 or better.
• Able to take oral medication (KI).
• Written informed consent available.

You may not qualify if:

• Renal mass known to be a metastasis of another primary tumor.
• Known histology of renal mass (e.g. by biopsy).
• Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
• Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to Iodine (124I) Girentuximab infusion on Day 0 or continuing adverse effects (\>grade 1) from such therapy.
• Exposure to murine proteins or chimeric antibodies within the last 5 years.
• Intercurrent medical condition that may limit patient's study participation or compliance.
• History of autoimmune hepatitis.
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
• Women who are pregnant or breastfeeding.
• Contraindication to KI intake (see package insert/Appendix VI).
• Hyperthyroidism, or Grave's Disease.
• Contraindication for PET/CT.

Sponsors & Collaborators

• Heidelberg Pharma AG: lead

Study Sites (8)

David Geffen School of Medicine, UCLA

Los Angeles, California, 90095-1721, United States

Location

H. Lee Moffitt Cancer Center & Research Center

Tampa, Florida, 33612, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27711, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MD Anderson

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Iodine; G250 monoclonal antibody

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Halogens; Elements; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 7, 2013
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

US (8)