Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01712685
Other study ID # 130018
Secondary ID 13-C-0018
Status Terminated
Phase Phase 2
First received October 20, 2012
Last updated January 10, 2017
Start date October 2012
Est. completion date August 2013

Study information

Verified date January 2017
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Background:

- The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans. Researchers want to see how well it works for scans for people who have kidney cancer.

Objectives:

- To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney cancer.

Eligibility:

- Adults at least 18 years of age with kidney cancer that will be treated with surgery.

Design:

- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.

- Participants will have two positron emission tomography (PET) scans of their kidneys. They will have the scans before and after receiving an injection of 18F-VM4-037. The scans will take about 2 hours to complete.

- About 3 weeks after the PET scans, participants will provide tumor tissue samples from their kidneys.

- This is a scanning study only. Treatment will not be provided as part of this study.


Description:

BACKGROUND:

- Carbonic Anhydrase IX (CA IX) is a hypoxia-inducible enzyme regulated by the Von Hippel Lindau (VHL) protein that is commonly overexpressed in certain malignancies including renal cell carcinoma (RCC) and may have prognostic significance.

- The VHL gene is commonly mutated or inactivated in RCC tumors and VHL activity regulated the expression and activity of not only CAIX but also CAXII as well as other genes critical for tumor angiogenesis such as vascular endothelial growth factor (VEGF), glucose transporter 1 (GLUT1), glucose transporter 3 (GLUT 3) and platelet derived growth factor (PDGF).

- 18F-VM4-037 is an imaging drug product formulation which binds to the active site ligand of CA-IX and also binds to CAXII. We propose to evaluate 18F-VM4-037 as a positron emission imaging (PET) radiopharmaceutical for the in vivo detection of CA-IX and CAXII in renal tumors.

STUDY OBJECTIVES

PRIMARY OBJECTIVE:

- To evaluate the biodistribution of 18F-VM4-037 within tumor and non-tumor tissues.

- To assess safety of 18F-VM4-037 in patients with primary or metastatic RCC.

ELIGIBILITY:

- Subject is greater than or equal to 18 years old, Eastern Cooperative Oncology Group (ECOG) 0-2.

- Subject must have confirmed primary RCC (greater than or equal to 2.5cm) in diameter on conventional imaging modality or extrarenal/extrahepatic RCC lesion (greater than or equal to 1cm).

DESIGN:

- Twenty subjects with primary RCC greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic lesion suspicious for metastatic RCC (greater than or equal to 1cm in diameter) scheduled for clinically indicated surgery or biopsy will undergo dynamic 18F-VM4-037 PET/CT imaging. Results will be compared with pathology.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - INCLUSION CRITERIA:

- Subject is greater than or equal to18 years old.

- Subject must be scheduled to undergo surgery or biopsy for primary renal cell carcinoma (RCC) greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic metastatic RCC lesion (greater than or equal to1cm in diameter) at the National Institutes of Health (NIH) Clinical Center based on imaging within 3 weeks.

- Chemistry parameters: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2 times of the upper limits of normal; total bilirubin, of < 2 times the upper limits of normal or < 3.0 mg/dl in patients with Gilberts syndrome.

- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.

- Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

- The subject has a clinically acceptable medical history, physical examination and vital signs findings during the screening period (from within 21 days before administration of 18F-VM4-037). Components of an acceptable medical history include no active infection at the time of enrollment or within 7 days of enrollment, no prior therapy that results in immunocompromise or impaired renal function (serum creatinine within 2 weeks prior to positron emission tomography (PET) imaging less than or equal to1.8 mg/dl and epidermal growth factor receptor (eGFR) must be > 30 ml/min/1.73m^2) or findings indicating an inability to tolerate the requirements for the scan. Previous exposure to immunocompromising therapy does not exclude the patient; patients must have an absolute neutrophil count > 1.5/microL within 2 weeks of PET imaging.

- If female, must have a negative serum human chorionic gonadotropin (HCG) within 24 hours prior to 18F-VM4-037 injection OR be post menopausal for > 2 years OR be surgically sterile.

EXCLUSION CRITERIA:

- Subjects for whom participating would significantly delay the scheduled standard of care therapy.

- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.

- Subjects with severe claustrophobia unresponsive to oral anxiolytics.

- Other medical conditions deemed by the principle investigator (or associates) or sponsor to make the subject ineligible for protocol procedures.

- Female subject is pregnant or nursing

- The site of the target lesion must not have been part of a radiation portal within 6 months of enrollment.

- Subjects having received another investigational agent within 1 month before administration of 18F-VM4-037.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
18F-VM4-037
Drug being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans.
Procedure:
PET/CT


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society.. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. Review. — View Citation

Latif F, Tory K, Gnarra J, Yao M, Duh FM, Orcutt ML, Stackhouse T, Kuzmin I, Modi W, Geil L, et al. Identification of the von Hippel-Lindau disease tumor suppressor gene. Science. 1993 May 28;260(5112):1317-20. — View Citation

Seizinger BR, Rouleau GA, Ozelius LJ, Lane AH, Farmer GE, Lamiell JM, Haines J, Yuen JW, Collins D, Majoor-Krakauer D, et al. Von Hippel-Lindau disease maps to the region of chromosome 3 associated with renal cell carcinoma. Nature. 1988 Mar 17;332(6161):268-9. — View Citation

Turkbey B, Lindenberg ML, Adler S, Kurdziel KA, McKinney YL, Weaver J, Vocke CD, Anver M, Bratslavsky G, Eclarinal P, Kwarteng G, Lin FI, Yaqub-Ogun N, Merino MJ, Linehan WM, Choyke PL, Metwalli AR. PET/CT imaging of renal cell carcinoma with (18)F-VM4-03 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs) The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both "non-tumor" tissue. 58 days No
Secondary Number of Participants With Adverse Events Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. 58 days Yes
Secondary Mean Standard Uptake Value (SUV) for All Target Lesions Mean SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. No
Secondary Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC) Mean SUV for primary clear cell renal carcinoma was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. No
Secondary Mean Standard Uptake Value (SUV) for Normal Kidney Mean SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. No
Secondary Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories. 21 days prior to enrollment until closure of the study, approximately 14 months. No
Secondary Distribution Volume Ratio (DVR) for the Primary Kidney Lesions DVR of the lesions was measured by the Logan graphical analysis method. Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. No
Secondary Time to Peak Activity Derived From Time Activity Curve (TAC) The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility. Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. No
Secondary Kinetic (Ki) Rate Constant Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki. Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. No
See also
  Status Clinical Trial Phase
Completed NCT02248389 - Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses Phase 1
Completed NCT03900364 - a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy N/A
Completed NCT00158782 - Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients Phase 1
Completed NCT03109015 - Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing Phase 2
Completed NCT00363194 - A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients Phase 1
Completed NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
Completed NCT00842790 - Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging N/A
Completed NCT00529802 - Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer Phase 2
Completed NCT00356460 - Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma Phase 1
Completed NCT00338884 - Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer Phase 2
Completed NCT00387764 - Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer Phase 3
Completed NCT00095186 - Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma Phase 2
Completed NCT00043368 - PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909) Phase 2
Completed NCT00079612 - Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer Phase 2
Active, not recruiting NCT04489771 - A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013) Phase 2
Completed NCT00516672 - Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors Phase 1
Withdrawn NCT05104905 - A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma Phase 1/Phase 2
Terminated NCT03685591 - PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Phase 1
Withdrawn NCT03111901 - Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer Phase 1/Phase 2
Recruiting NCT05544929 - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Phase 1