A Phase 2 interventional study of Vorinostat in Recurrent Renal Cell Carcinoma and Stage IV Renal Cell Cancer, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial is studying how well vorinostat works in treating patients with advanced kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of vorinostat (SAHA), in terms of objective response and progression rate, in patients with advanced renal cell carcinoma.
SECONDARY OBJECTIVES:
I. Evaluate the safety and tolerability of this drug, in terms of toxicity profile, in these patients.
II. Evaluate overall survival, progression-free survival, and survival rate at 12 months in patients treated with this drug.
III. Correlate changes in biologic measurements with outcomes of patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator.
After completion of study treatment, patients are followed within 1 month and then approximately every 2 months thereafter.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 14 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator.
Drug: Vorinostat
Given orally
Also known as: L-001079038, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
Objective Response
Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria. Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: 1 year
Progression-free Survival
Time frame: 1 year
Overall Survival (OS) and Median OS
Time frame: 1 year
Safety and Tolerability
Time frame: 1 year
Open to recruitment on 12/5/2005, closed to recruitment on 3/3/09 at The University of Texas Health Science Center San Antonio at Cancer and Therapy Research Center
| Milestone | Vorinostat |
|---|---|
| Started | 14 |
| Completed | 11 |
| Not completed | 3 |
| Withdrew: Adverse event | 2 |
| Withdrew: Nonevaluable | 1 |
Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria. Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
| participants | Vorinostat |
|---|---|
| Best Objective Response Rate (ORR) | 4 |
| Progressive Disease | 7 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vorinostat | — | 1/14 (7.1%) | 7/14 (50%) |
| Event | Vorinostat |
|---|---|
| Shortness of BreathRespiratory, thoracic and mediastinal disorders | 1/14 |
| Congestive Heart FailureCardiac disorders | 1/14 |
| Event | Vorinostat |
|---|---|
| NauseaGastrointestinal disorders | 7/14 |
| FatigueBlood and lymphatic system disorders | 7/14 |
| Weight lossGastrointestinal disorders | 6/14 |
| DiarrheaGastrointestinal disorders | 4/14 |
| VomitingGastrointestinal disorders | 4/14 |
| Age, Categorical(Participants) | Vorinostat |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 2 |
| Age, Continuous(years) | Vorinostat |
|---|---|
| Mean | 60 ± 2 |
| Sex: Female, Male(Participants) | Vorinostat |
|---|---|
| Female | 5 |
| Male | 9 |
| Region of Enrollment(participants) | Vorinostat |
|---|---|
| United States | 14 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)