Kidney Cancer Clinical Trial
Official title:
Neoadjuvant Everolimus(RAD001)for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01)
The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover
if Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal
cell carcinoma - RCC).
Since 2002, Everolimus has been studied in more than 2500 patients with various types of
cancer as a single agent (a drug that is used alone to treat the cancer) or in combination
with a number of well known anticancer therapies. Various studies, in animals such as in
mice with cancer and in humans with cancer have shown that Everolimus can slow the growth of
cancer.
Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to
remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be
resumed at the same dose.
Everolimus has significantly improved outcomes following prior therapy. This study is a biomarker driven Phase II trial that will assess the activity of everolimus as first-line therapy for renal cell carcinoma. Following initial kidney tumor biopsy, everolimus is administered for 3-5 weeks before cytoreductive nephrectomy and everolimus is then resumed and continued until tumor progression or intolerable toxicities. Any correlation of tumor tissue biomarker changes from initial biopsy to nephrectomy specimen with long-term progression-free survival will be determined. This trial may enable the identification of factors predictive of significant benefit from everolimus administered as first-line therapy by employing the neoadjuvant therapy paradigm. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00541008 -
Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
|
Phase 2 | |
| Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
| Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
| Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
| Completed |
NCT01048892 -
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
|
Phase 1 | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| Withdrawn |
NCT00769990 -
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
|
Phase 1/Phase 2 | |
| Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A | |
| Recruiting |
NCT00301990 -
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00098943 -
NGR-TNF in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00467077 -
Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
|
Phase 2 | |
| Terminated |
NCT00899860 -
Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer
|
N/A | |
| Terminated |
NCT00089102 -
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00021021 -
RPI.4610 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00006968 -
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 |