Clinical trial · Interventional
Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage III Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| isotretinoin | Drug | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vorinostat and isotretinoin)
- description
- Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: vorinostat
- Drug: isotretinoin
Primary outcomes (3)
- measure
- Number of Participants With at Least One Dose Limiting Toxicity Associated With Vorinostat Concurrently Administered With Isotretinoin
- timeFrame
- Course 1, up to 28 days
- description
- 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
- measure
- Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available