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Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets

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ClinicalTrials.gov Identifier: NCT02353429
Recruitment Status : Unknown
Verified January 2015 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Collaborator:
Associazione Italiana per la Ricerca sul Cancro
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:

This is a prospective study evaluating the activity and the safety of toremifene in patients with primary or recurrent sporadic DTs.

Patients will be enrolled after the histological confirmation of DTs on biopsy Patients will start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will be performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale (VAS) every 3 months for the first and second year, twice yearly thereafter. Response will be evaluated either by RECIST and/or symptomatic relief.


Condition or disease Intervention/treatment Phase
Desmoid Type-fibromatosis Drug: Toremifene Phase 2

Detailed Description:

This is a prospective study evaluating the activity and the safety of toremifene in patients with primary or recurrent sporadic DTs.

Patients will be enrolled after the histological confirmation of DTs on biopsy performed at the investigators institution or after the pathological review of tissue specimen obtained via needle biopsy or surgical excision (in case of recurrence) performed elsewhere. A new biopsy will be performed if the amount of tissue will not be sufficient for immunohistochemical analysis. Patients will start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will be performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale (VAS) every 3 months for the first and second year, twice yearly thereafter. Response will be evaluated either by RECIST and/or symptomatic relief.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets
Study Start Date : November 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Toremifene treatment
Patients will receive 60 mg daily of Toremifene and the dose will be escalated to 180 mg daily in case of progression
Drug: Toremifene
Patients will receive 60 mg daily and then 180 daily in case of progression




Primary Outcome Measures :
  1. Time to progression [ Time Frame: 2 years ]
    This study evaluates clinical benefit by comparing sequentially measured paired failure times within each treated patient, namely time to progression after the 60 mg toremifene dose (TTP1) versus the (possibly censored) time to progression after the 180 mg toremifene dose (TTP2)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age > 18 years) with primary or locally recurrent, sporadic or FAP associated, desmoid fibromatosis
  • Histologically documented diagnosis of DF
  • At least one measurable site of disease at CT or MRI scans, which has not been previously embolised or irradiated
  • Progressive disease demonstrated at contrast-enhanced MRI or CT scan by Response Evaluation Criteria in Solid Tumors (RECIST)
  • Radiologic or clinical evidence of PD in the previous 6 months. Radiologic PD will be defined according to RECIST
  • ECOG Performance status: 0-2
  • Prior hormonal therapy, chemotherapy, or molecular targeted therapies are allowed
  • Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L
  • Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
  • Life expectancy of at least 6 months
  • Written, voluntary, informed consent.

Exclusion Criteria:

  • Previous history of deep vein thrombosis
  • Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/√RR) or history of familial long QT syndrome
  • Previous arrhythmia
  • Clinically significant bradycardia
  • Endometrial hyperplasia
  • Hepatic insufficiency
  • Other concurrent hormonal therapy, including hormonal contraceptives
  • Patient has received any other investigational agents within 28 days of first day of study drug dosing. - Female patients who are pregnant or breast-feeding
  • Patient has a severe and/or uncontrolled medical disease
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
  • Patient received chemotherapy within 4 weeks prior to study entry
  • Patient had a major surgery within 2 weeks prior to study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353429


Contacts
Contact: Chiara Colombo, MD +39022390 ext 3234 chiara.colombo@istitutotumori.mi.it
Contact: Lorella Rusi, MD +39022390 ext 3714

Locations
Italy
Fondazione IRCCS Istituto Tumori Milano Recruiting
Milan, Italy, 20133
Contact: Chiara Colombo, MD    +39023903234    chiara.colombo@istitutotumori.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Associazione Italiana per la Ricerca sul Cancro
Investigators
Principal Investigator: Chiara Colombo, MD Fondazione IRCCS Istituto Tumori Milano

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02353429     History of Changes
Other Study ID Numbers: INT 112/11
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Fibromatosis, Aggressive
Fibroma
Toremifene
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents