Kidney Cancer Research & Trials

Phase 2 Study of Neoadjuvant Cabozantinib in Patients with Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria:

• Pathologically advanced ccRCC

• Metastatic disease as per RECIST 1.1 and iRECIST criteria

• Eligible for standard first-line therapy

Exclusion Criteria:

• Systemic therapy for any malignancy

• History of known brain metastases, spinal cord compression, carcinomatous meningitis, or evidence of brain or leptomeningeal disease 

• Active Infectious disease status

Principal Investigator:

Viraj Master, MD, PhD

A Phase 2 Study of Neoadjuvant Cabozantinib in Patients with Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria:

• Renal mass consistent with a clinical stage ≥ T3Nx or TanyN+ or deemed unresectable by surgeon

• Locally advanced renal cell carcinoma without evidence of metastatic disease

• Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor

• Patient should be candidate for curative radical nephrectomy

• ECOG performance status ≤ 1

• No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy, in the five years prior to current study enrollment

Exclusion Criteria:

• Evidence of metastatic disease on pre-treatment imaging

• The subject has received any type of cytotoxic, biologic, or other systemic anti-cancer therapy

• Known brain metastases or cranial epidural disease

• Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel)

Principal Investigator: 

Viraj Master, MD, PhD

Co-Principal Investigator: 

Mehmet Bilen, MD (Department of Hematology and Medical Oncology)

Co-Investigators: 

Haydn Kissick, PhD, Kenneth Ogan, MD

Department of Hematology and Medical Oncology: Bradley Carthon, MD, PhD, Omer Kucuk, MD, David Lawson, MD

Neoadjuvant Lenvatinib with Pembrolizumab in Patients with Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria:

• Renal mass consistent with a clinical stage ≥ T3Nx or TanyN+ or deemed unresectable by surgeon

• Locally advanced renal cell carcinoma without evidence of metastatic disease

• Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor

• ECOG performance status ≤ 1 

• No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy 5 years prior

Exclusion Criteria:

• Evidence of metastatic disease on pre-treatment imaging

• The subject has received any type of cytotoxic, biologic or other systemic anticancer therapy for kidney cancer

• The subject has received any other type of investigational agent within 28 days before the first dose of study treatment

• Subjects must have recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy

Principal Investigator:

Viraj Master, MD, PhD

Co-Principal Investigator:

Mehmet Bilen, MD (Department of Hematology and Medical Oncology)

Co-Investigators & Collaborators:

Haydn Kissick, PhD, Viraj Master, MD, PhD

Department of Hematology and Medical Oncology: Jacqueline Brown, MD, Christine Ertley, PA, Sarah Friend, MD, Jamie Goldman, MD, Julia Green, NP, Emilie Hitron, NP, Andrea Huffman, PA-C, Omer Kucuk, MD, David Lawson, MD, Neela Natarajan, MD, Greta Russler, MSN, FNP-BC, Stephen Szabo, MD, Lauren Yantorni, NP

Department of Biostatistics and Bioinformatics: Yuan Liu, PhD, MS

Emory Healthcare/Winship Cancer Institute: Meredith Foushee, PA, Necia Maynard, NP, ANP-BC

Glycosaminoglycan Scores for Surveillance of Recurrence in Liebovich Points >/= Non-Metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria:

• Pre-op abdominal CT-scan
  – Primary tumor > 4cm (> cT1a)
  OR
  – ≤ 4cm if sign of venous tumor thrombus

• Elected for curative intent surgery for RCC

Exclusion Criteria:

• Metastatic disease at diagnosis

• No chest CT within 60 days before surgery

• History of other cancers not deemed fully cured

• Any other therapy than curative surgery

Principal Investigator: 

Viraj Master, MD, PhD

Co-Investigators & Collaborators: 

Kenneth Ogan, MD, Shreyas Joshi, MD

Pilot Study of Biomarker Evaluation and Safety of Pre-Incisional Ketorolac for Patients Undergoing Surgical Resection for Non-Small Cell Lung Cancer and Renal Cell Carcinoma

Inclusion Criteria:

• Pathology-proven or suspected stage 1 or 2 NSCL and Stage 3 T3N0 RCC that require surgical resection as the treatment of choice

• ECOG performance status (PS) 0, 1, or 2

• Age ≥ 18 years and ≤ 80 years

Exclusion Criteria:

• Individuals with pure lung ground-glass opacity (GGO) lesions or mixed GGO with < 50% solid component

• Patients undergoing pneumonectomy

• History of cancer in the 3 years prior to surgery (except for basal-cell carcinoma of the skin or cervical neoplasia)

• Contraindication for NSAIDs (peptic ulcer disease, pre-operative chronic kidney disease with eGFR < 60 measured with the MDRD equation used widely, including at Emory), allergies or intolerance to NSAIDs, coagulation disorder, or age > 80 years)

• Having taken an NSAID within 5 days prior to surgery

• Immunocompromised status

• Refusal or inability to understand the protocol and consent form or to receive follow-up in line with the recommendations

• Preoperative hemoglobin < 9.0

Principal Investigator: 

Viraj Master, MD, PhD

Co-Investigators & Collaborators:

Rebecca Arnold, PhD, MS, Shreyas Joshi, MD, Hadyn Kissick, PhD, Vikram Narayan, MD, Emily McDowell, PA-C, Kenneth Ogan, MD

Department of Surgery: Felix Fernandez, MD, MSc, Seth Force, MD, Onkar Khullar, MD, Manu Sancheti, MD

Department of Biostatistics and Bioinformatics: Manoj Bhasin, PhD, MD, Yuan Liu, PhD, MS

Emory Investigational Drug Service: Susan Rogers, BS Pharm, RPh

A Confirmatory, Prospective, Open-Label, Multi-Centre Phase 3 Study to Evaluate Diagnostic Performance of 89Zirconium-Labelled Girentuximab(89Zr-TLX250) to Non-Invasively Detect Clear Cell Renal Cell Carcinoma (Ccrcc) by Positron Emission Tomography/CT (PET/CT) Imaging in Patients with Indeterminate Renal Masses

Inclusion Criteria:

• Imaging evidence of a single indeterminate renal mass of ≤ 7 cm in the largest diameter (stage cT1) suspicious for ccRCC, on MRI or equivalent standard of care imaging with contrast agent; imaging must be done within 90 days before screening 

• Schedule for lesion resection (partial or total nephrectomy) within 90 days of IP administration 

Exclusion Criteria:

• Renal mass is known to be a metastasis of another primary tumor; pts with a single indeterminate renal mass and metastasis are eligible

• Active non-renal malignancy 

• Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned IP administration 

• Planned antineoplastic therapies 

• Women who are pregnant or breastfeeding 

• Renal insufficiency with GFR ≤ 45 mL/min/1.73 m2

Principal Investigator:

Viraj Master, MD, PhD

Co-Principal Investigator: 

David Schuster, MD (Department of Radiology and Imaging Sciences)

Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Tumors

Inclusion Criteria:

• Renal masses ≥ cT2

• N1 or M1 disease for surgical candidates

• Ejection fraction (EF) ≥ 45% by ECHO

Exclusion Criteria:

• Non-surgical candidate

• Unstable angina

Principal Investigator:

Viraj Master, MD, PhD

Co-Investigators & Collaborators: 

Kenneth Ogan, MD

Department of Anesthesiology: Gaurav Patel, MD, Kati Running, MD