Kidney Cancer Clinical Trial
Official title:
Phase I/II Study of Subcutaneous Administration of Pegylated-Interferon Alpha-2A (RO 25-8310) in Previously Untreated Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients
with advanced kidney cancer.
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of pegylated-interferon alfa-2a in
patients with advanced or metastatic renal cell carcinoma. II. Evaluate the safety profile
of the MTD in this patient population. III. Determine the objective response rate, time to
response, duration of response, time to progression, and survival rate in this patient
population.
OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive
pegylated-interferon alfa-2a (PEG-IFN) subcutaneously once a week for 24 weeks. Dose
escalation of PEG-IFN continues until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicity. After the MTD of PEG-IFN is determined, additional patients are treated at this
dose level. These patients may continue treatment after the first 24 weeks for up to 1 year,
in the absence of disease progression. Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 46-58 patients will be accrued for this study within 9 months.
;
Primary Purpose: Treatment
| 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 | |
| Withdrawn |
NCT00769990 -
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
|
Phase 1/Phase 2 | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| 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 |