Vorinostat in Treating Patients With Kidney Cancer

NCT00278395 | Completed Phase 2 Results

• 5 other identifiers: NCI-2009-00087CDR0000456500#04-106825U01CA069853
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Progression-free Survival

  1 year

• Overall Survival (OS) and Median OS

  1 year

• Safety and Tolerability

  1 year

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

Vorinostat DRUG

Given orally

Also known as: L-001079038, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma that is either metastatic or inoperable
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Disease is recurrent or refractory to interleukin-2 (IL-2) or interferon-based therapy OR new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 based treatment
• Patients who have failed up to 4 lines of prior immunotherapy or biological therapy allowed
• No known brain metastases or leptomeningeal disease
• Stable brain metastases or curatively resected brain metastases without neurologic dysfunction for ≥ 6 months allowed
• ECOG performance status 0-2 OR Karnofsky 70-100%
• Life expectancy ≥ 12 weeks
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance \> 50 mL/min
• Total bilirubin within normal limits
• AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
• No history of active malignancy (other than renal cell carcinoma) within the past 3 years other than nonmelanomatous skin cancer, in situ breast cancer, or in situ cervical cancer

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Institute for Drug Development

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Results Point of Contact

• Title: Dr. John Sarantopoulos
• Organization: University of Texas Health Science Center at San Antonio

sarantopoulo@uthscsa.edu

210-450-1000

Study Officials

• John Sarantopoulos

  Institute for Drug Development

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: October 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 14, 2017
• Results First Posted: August 30, 2013

Record last verified: 2017-10

Locations

US (2)