Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response

NCT00694096 | Completed Phase 1 Results DMC

• 1 other identifier: HCI21897
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory clinical study is designed to obtain pre-therapeutic imaging assessments in 20 evaluable patients with metastatic renal cell cancer (RCC) and an early post therapy assessment at baseline and at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients and 4 weeks in 5 patients) after institution of standard approved sunitinib therapy at 37.5 mg/day. The clinical imaging biomarkers will include an assessment of tumor metabolism \[Bannasch 1986, Frauwirth 2002, Garber 2006, Kelloff 2005, Pauwels 1998, Semenza 2001, Smith 1999, Smith 2000, Sokoloff 1977, Warburg 1956, Weber 1977A, Weber 1977B\] (dynamic FDG-PET); tumor proliferation \[Rasey 2002,Shields 2001, Shields 1998, Vesselle 2002, Schwartz 2003\] (dynamic FLT-PET); tumor blood flow (H215O-PET, DCE MRI)\[Lodge 2000\], tumor perfusion (DCE-MRI)\[Tofts 1999, Tofts 1997, Parker 1999\]; and tumor blood volume (H215O-PET, DCE MRI)\[Lodge 2000, Tofts 1999, Tofts 1997\] in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks). We hypothesize that by using this set of imaging assessments it will be possible to determine an individual or more likely a set of imaging derived biomarkers that will accomplish several of the goals of the initiative which is providing funding for the study.

Conditions

Renal Cell Cancer

Outcome Measures

Primary Outcomes (2)

• Metabolic Response

  Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) \< 25% change in SUVmax.

  4 weeks

• Proliferative Response

  Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) \< 25% change in SUVmax.

  4 weeks

Secondary Outcomes (1)

• Overall Survival

  2399 days

Study Arms (1)

1

EXPERIMENTAL

Drug: Sunitinib

Interventions

Sunitinib DRUG

Imaging studies with complete analyses will be provided on all patients prior to institution of sunitinib therapy as well as after therapy at various early time points (1 week in 5 patients, 2 weeks in 5 patients, 3 weeks in 5 patients or 4 weeks in 5 patients) after institution of sunitinib therapy at 37.5 mg orally/day. Imaging studies include: FDG-PET scans FLT-PET scans H215O-PET scans DCE-MRI scans

Also known as: Sutent®

1

Eligibility Criteria

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

You may qualify if:

• After entry into the study, patients are expected to be followed for at least 2 months as part of standard of care.
• All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
• The patient, if female, must be postmenopausal for a minimum of one year or surgically sterile, or on one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera or Norplant. These criteria can be waived at the discretion of the investigator if the patient's tumor is considered life threatening and the one month wait required is not in the best interest of the patient. Negative pregnancy test is accepted.
• Pre-treatment laboratory tests for patients receiving \[F-18\]FLT must be performed within 21 days prior to study entry. These must be less than 4 times below or above the upper or lower limit range for the respective laboratory test. These will include liver enzymes (SGOT, SGPT, ALK Phos, GGT, LDH), bilirubin (direct and total), amylase, serum electrolytes, CBC with platelets and absolute neutrophil counts, prothrombin time, partial thromboplastin time, BUN, creatinine, and urinalysis.
• Pre-treatment radiological clinical scans/studies (Gd- enhanced MRI or CT to document metastatic renal cell carcinoma) must be performed within 30 days of study entry.

You may not qualify if:

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals or Gd used in MRI imaging. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
• Patients who are pregnant or lactating or who suspect they might be pregnant.
• Adult patients who require monitored anesthesia for PET or MRI scanning.
• HIV positive patients due to the previous toxicity noted with FLT.
• Presence of any ferromagnetic metallic implants or foreign bodies, including pacemakers and certain types of stents and orthopedic hardware.
• Claustrophobia or inability to remain stationary within MRI system for \~30-45 minutes.
• Inability to breath hold for periods of at least 20 seconds.
• Known history of adverse reaction to Gd chelate contrast agents.
• Pregnancy or breastfeeding.
• Non-imageable tumor, including tumors with smallest dimension less than 10mm or tumors located in regions excessively affected by susceptibility artifacts at bone- and air-tissue interfaces or motion artifacts due to peristalsis or pulsatile flow.

Sponsors & Collaborators

• University of Utah: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Horn KP, Yap JT, Agarwal N, Morton KA, Kadrmas DJ, Beardmore B, Butterfield RI, Boucher K, Hoffman JM. FDG and FLT-PET for Early measurement of response to 37.5 mg daily sunitinib therapy in metastatic renal cell carcinoma. Cancer Imaging. 2015 Sep 3;15(1):15. doi: 10.1186/s40644-015-0049-x.

  PMID: 26335224 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney 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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mark Wade, Ph.D. - Compliance Officer
• Organization: Huntsman Cancer Institute

mark.wade@hci.utah.edu

801-213-5746

Study Officials

• John M Hoffman, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 1, 2015
• Results First Posted: December 1, 2015

Record last verified: 2015-10

Locations

US (1)