NCT00121225

Brief Summary

This phase II trial is studying how well vorinostat works in treating patients with metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 3, 2014

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

July 19, 2005

Results QC Date

October 1, 2014

Last Update Submit

January 9, 2019

Conditions

Ciliary Body and Choroid Melanoma, Medium/Large SizeExtraocular Extension MelanomaIris MelanomaUveal MelanomaRecurrent Intraocular MelanomaRecurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

    Per Response Evaluation Criteria in Solid Tumours Criteria (RECIST v1.0) for target lesions and are assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in sum of longest diameter of target lesions; Objective Response (OR) = CR+ PR.

    Up to 5 years

Secondary Outcomes (4)

  • Time to Progression Assessed by RECIST

    Up to 5 years

  • Difference in HP1 and MacroH2A Nuclear Foci Expression Between Progressive Minus Stable Disease Outcomes

    Baseline and day 15

  • Number of Patients With p53 Allelic Variations (72R or 72P)

    Baseline

  • Comparison of VEGF Serum Levels to Response to Vorinostat

    Baseline, Day 1, Day 8 and Day 15

Study Arms (1)

Arm I

EXPERIMENTAL

Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

Drug: vorinostat

Interventions

vorinostatDRUG

Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically/cytologically confirmed melanoma that is metastatic/unresectable
  • Residual, recurrent, or metastatic disease by radiographic examination. Measurable disease (at least 1 lesion in at least 1 dimension (longest diameter) as \>20mm with conventional techniques or \>10mm with spiral CT scan, within 4 weeks prior to registration
  • No prior therapy or 1 prior treatment (cytokine/chemotherapy/combination) for metastatic disease allowed. Patients should not take valproic acid, another histone deacetylase inhibitor, for at least 2 weeks prior to enrollment. At least 4 weeks from prior therapy to be eligible or 6 weeks if last regimen included BCNU or mitomycin C
  • Age\>=18 years
  • Life expectancy \>=3 months.
  • ECOG\<2 (Karnofsky ≥60%)
  • Leukocytes \>3,000/mcL
  • Absolute neutrophil count \>1,500/mcL
  • Platelets \>100,000/mcL
  • Total bilirubin within institutional limits
  • AST/ALT≤2.5Xinstitutional ULN
  • Creatinine within institutional limits OR creatinine clearance \>60mL/min/1.73 m2 if creatinine levels above institutional limits
  • Eligibility of patients taking medications with potential to affect activity/PK of Vorinostat will be determined by PI
  • Must not use concomitant steroids except topical/inhaled use
  • Vorinostat effects on developing human fetus are unknown. Women of childbearing potential (WOCBP) and sexually active males must agree to use accepted/effective contraception method prior to study entry and for duration of the study
  • +2 more criteria

You may not qualify if:

  • Chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study
  • May not be receiving any other investigational agents
  • Known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical/biologic composition to Vorinostat
  • Uncontrolled intercurrent illness including but not limited to ongoing/active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women excluded because Vorinostat is a HDAC inhibitor agent with potential for teratogenic or abortifacient effects
  • HIV-positive patients receiving combination antiretroviral therapy are ineligible because of potential for PK interactions with Vorinostat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Fox Chase Cancer Center

Rockledge, Pennsylvania, 19046, United States

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Haas NB, Quirt I, Hotte S, McWhirter E, Polintan R, Litwin S, Adams PD, McBryan T, Wang L, Martin LP, vonMehren M, Alpaugh RK, Zweibel J, Oza A. Phase II trial of vorinostat in advanced melanoma. Invest New Drugs. 2014 Jun;32(3):526-34. doi: 10.1007/s10637-014-0066-9. Epub 2014 Jan 25.

    PMID: 24464266RESULT

MeSH Terms

Conditions

Uveal MelanomaMelanoma

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Results Point of Contact

Title
Dr. David Hogg
Organization
Princess Margaret Cancer Centre
david.hogg@uhn.ca
416-946-4501

Study Officials

  • Naomi Balzer-Haas

    Princess Margaret Hospital Phase 2 Consortium

    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

July 19, 2005

First Posted

July 21, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2009

Study Completion

June 1, 2013

Last Updated

January 29, 2019

Results First Posted

October 3, 2014

Record last verified: 2019-01

Locations

CA(3)US(2)