Kidney Cancer Clinical Trial
Official title:
Phase IB Open-Label Rising-Dose Study of Biomed 101 in Patients Treated With Interleukin-2 for Malignancy
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer
cells. Biomed 101 may protect normal cells from the side effects of interleukin-2.
PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients
receiving interleukin-2 for kidney cancer.
OBJECTIVES: I. Evaluate the safety and maximum tolerated dose of Biomed 101 in patients with
renal cell cancer currently treated with interleukin-2 (IL-2). II. Evaluate the effect of
different doses of Biomed 101 on the incidence and severity of IL-2 related toxicities and
on the incidence and frequency of IL-2 dose reduction due to IL-2 induced toxicity.
OUTLINE: This is a dose escalation study of Biomed 101. Patients receive oral Biomed 101
three times daily, followed by interleukin-2 IV on days 1-5 and 16-20. Cohorts of 5 patients
receive escalating doses of Biomed 101 until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience
dose limiting toxicities. Patients are followed for 1 month.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
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 | |
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 |
NCT00089102 -
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced 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 | |
Completed |
NCT00021021 -
RPI.4610 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 | |
Completed |
NCT00006968 -
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
|
Phase 1/Phase 2 |