NCT00024011

Brief Summary

Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic malignant melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

February 6, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

5.2 years

First QC Date

September 13, 2001

Last Update Submit

January 15, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who are progression-free

    Confidence intervals for the true success proportion will be calculated.

    18 weeks

Secondary Outcomes (2)

  • Objective response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) in terms of tumor/lesion size and change

    Up to 2 years

  • Overall survival

    Time from registration to death due to any cause, assessed up to 2 years

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: bortezomibOther: laboratory biomarker analysis

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (bortezomib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bortezomib)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed metastatic malignant melanoma
  • Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as \>= 2.0 cm
  • Absolute neutrophil count (ANC) \>= 1500/uL
  • PLT \>= 100,000/uL
  • Total bilirubin =\< 2.5 x institutional upper normal limit (UNL)
  • AST =\< 2.5 x UNL
  • Creatinine =\< 1.5 x UNL or calculated creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 x UNL using the Cockcroft-Gault formula
  • Life expectancy of \>= 3 months
  • ECOG performance status 0 or 1
  • Capable of understanding the investigational nature, potential risks and benefits of the study and willing to sign the written informed consent document

You may not qualify if:

  • Any of the following:
  • Any prior chemotherapy
  • Immunotherapy =\< 4 weeks prior to study entry
  • Biologic therapy =\< 4 weeks prior to study entry
  • Radiation therapy =\< 4 weeks prior to study entry
  • Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
  • Known brain metastases requiring active treatment; NOTE: these patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PS-341
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris, cardiac arrhythmia
  • Psychiatric illness that would limit compliance with study requirements
  • HIV-positive patients receiving combination anti-retroviral therapy; NOTE: patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; these patients are excluded from the study because of possible pharmacokinetic interactions with PS-341; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Svetomir Markovic

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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

September 13, 2001

First Posted

February 6, 2004

Study Start

July 1, 2001

Primary Completion

September 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)