NCT00165295

Brief Summary

The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy WM cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

September 9, 2005

Last Update Submit

June 23, 2011

Conditions

Waldenstrom's Macroglobulinemia

Keywords

sildenafil citrateViagraWaldenstrom's macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.

Interventions

Sildenafil citrate (Viagra)DRUG

Eligibility Criteria

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

You may qualify if:

  • Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
  • Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of \> 2 times the upper limit of each institution's normal value
  • Slowly progressing disease not requiring therapy for at least 3-6 months
  • ECOG performance status 0,1 or 2
  • Total bilirubin \< 2 x ULN
  • SGOT \< 3 x ULN
  • Creatinine \< 2 x ULN

You may not qualify if:

  • Pregnant or breast-feeding women
  • Patients who are using organic nitrates or alpha-blockers
  • Grade III/IV cardiac problems
  • Resting hypotension (BP \< 90/50) or hypertension (BP \> 170/110)
  • Cardiac failure or coronary artery disease causing unstable angina
  • Evidence of left ventricular outflow obstruction
  • Impaired autonomic control of blood pressure
  • Sickle cell anemia
  • History of priapism
  • Severe and/or uncontrolled medical disease
  • Known chronic liver disease
  • Currently using ritonavir
  • History of retinal pigmentosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Steven P. Treon, MD, MA, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

US(1)