Stage IV Renal Cell Cancer Clinical Trial
Official title:
A Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) in Combination With Isotretinoin (13-cis Retinoic Acid, 13-CRA) in the Treatment of Patients With Advanced Renal Cell Carcinoma
Verified date | February 2021 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I/II trial is studying the side effects and best dose of isotretinoin when given together with vorinostat and to see how well they work in treating patients with advanced kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may cause kidney cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may kill more tumor cells.
Status | Terminated |
Enrollment | 14 |
Est. completion date | May 2014 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Histologically or cytologically confirmed renal cell carcinoma - Advanced or metastatic disease - Measurable disease, defined as = 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (phase II only) - Failed = 2 prior treatment regimens, including chemotherapy, immunotherapy (i.e., interleukin or interferon), biological agents (i.e., kinase inhibitors), or combinations thereof - An overlap between classes of therapies given concurrently will be counted as 2 prior treatment regimens - No known brain metastases - ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% - Life expectancy > 3 months - WBC = 3,000/mm^3 - Absolute neutrophil count = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Bilirubin = 1.5 mg/dL - AST and ALT < 2.5 times upper limit of normal - Creatinine = 2 mg/dL OR creatinine clearance > 50 mL/min - Negative pregnancy test Exclusion criteria: - Not pregnant or nursing - No history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA), isotretinoin, or other agents or components (e.g., parabens) used in this study - No uncontrolled intercurrent illness, including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situation that would preclude study compliance - No concurrent antiretroviral therapy for HIV-positive patients - No other concurrent anticancer therapy, including radiation, biologic, or chemotherapeutic agents, for renal cell carcinoma or other tumors - No other concurrent investigational agents, valproic acid, or other retinoid |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Weill Medical College of Cornell University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With at Least One Dose Limiting Toxicity Associated With Vorinostat Concurrently Administered With Isotretinoin | Defined as the occurrence of one or more of the following toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | Course 1, up to 28 days | |
Primary | Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin | Hematologic: Any Grade 3/4 Thrombocytopenia and/or Grade 3/4 Neutropenia Non-Hematologic: Any >/= Grade3 non-hematologic toxicity considered by the investigator to be possibly related to study drug and/or any non-hematologic toxicity that results in a dose-delay of more than three weeks. | Once 2 DLT events occur in patients, the preceding dose will be designated the maximum tolerated dose (MTD). | |
Primary | Objective Response Rate | The Response Evaluation Criteria in Solid Tumors (RECIST 1.0) was used and tumor responses were defined as complete response (CR), partial response (PR), stable disease (SD) or Progression | Tumor measurements every 8 weeks until disease progression |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01740154 -
Sunitinib Malate Related Fatigue in Patients With Metastatic Kidney Cancer
|
N/A | |
Completed |
NCT00101114 -
Sorafenib and Interferon Alfa in Treating Patients With Metastatic or Unresectable Kidney Cancer
|
Phase 2 | |
Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Completed |
NCT03229278 -
Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma
|
Phase 1 | |
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Completed |
NCT01243359 -
Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT00278395 -
Vorinostat in Treating Patients With Kidney Cancer
|
Phase 2 | |
Terminated |
NCT00098618 -
Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00006486 -
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01684397 -
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT02273752 -
Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer
|
Phase 2 | |
Completed |
NCT01265368 -
A Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine in Patients With Advanced Renal Cell Carcinoma (ASET)
|
Phase 1/Phase 2 | |
Completed |
NCT00408902 -
Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00005799 -
Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
|
N/A | |
Completed |
NCT00019539 -
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
|
Phase 2 | |
Completed |
NCT02899078 -
Ibrutinib and Nivolumab in Treating Patients With Previously-Treated Metastatic Kidney Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02944617 -
Probiotic Yogurt Supplement in Reducing Diarrhea in Patients With Metastatic Kidney Cancer Being Treated With Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitor
|
N/A | |
Completed |
NCT01727089 -
Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
Completed |
NCT00499135 -
Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01943188 -
Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer
|
Phase 1 |