Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma (SNIPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Health Network, Toronto
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00843037
First received: February 12, 2009
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

This is an open-label phase II study of an investigational drug, sunitinib malate in patients with advanced malignant paraganglioma or phaeochromocytoma cancer. Paragangliomas (PGs) are tumours that arise from the para-sympathetic system in the head and neck and sympathetic system in the thorax and abdomen. Paragangliomas that secrete hormones (catecholamines) from the adrenal glands are called pheochromocytomas (PCs). In this study, patients whose disease has advanced or spread despite prior standard therapy, will receive sunitinib for 4-weeks followed by a 2-week rest period, for up to 12 months, in the absence of disease progression. Sunitinib is an investigational drug, which has been shown to shrink tumours in several tumour models. The study will evaluate the efficacy as well as the toxicity profile of sunitinib when used as an alternative treatment for patients with PG/PC tumours.


Condition Intervention Phase
Paraganglioma
Pheochromocytoma
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Clinical benefit rate (CBR) which is defined as either a partial response (PR) complete response (CR) or stable disease (SD) for ≥ 12 weeks measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. [ Time Frame: Every 12 weeks (2 cycles) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical response of > 20% drop in; 24-hour urinary metanephrines, catecholamines or serum chromogranin A, sustained for > 12-week period [ Time Frame: Patient specific based on disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Patient specific based on disease progression ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Patient specific based on disease progression ] [ Designated as safety issue: No ]
  • Overall response rate (PR) + (CR) [ Time Frame: Patient specific based on disease progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label - Sunitinib
Sunitinib, 50mg daily, once daily for 4 weeks followed by a 2-week break
Drug: Sunitinib
50 mg oral dose daily for 4 weeks, 2 week rest period (repeating 6 week cycles)
Other Name: Sunitinib malate (suntinib; SU11248, SU011248, Sutent®)

Detailed Description:

This study will be a single arm, open-label, phase II trial of sunitinib in patients with metastatic or locally advanced malignant paraganglioma or phaeochromocytoma. Oral sunitinib (50 mg) will be administered to all patients daily for the first four weeks of a six week study cycle, followed by a 2-week rest. Patients will be assessed for response to study treatment using MRI/CT scans as well as bio-chemical tests, and will receive the study treatment for up to 12 months or until disease progression.

Primary study outcomes include:

To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with advanced or metastatic paraganglioma/ pheochromocytoma.

To assess the toxicity of sunitinib in patients with advanced or metastatic paraganglioma/ pheochromocytoma.

To document effects of sunitinib on markers of biochemical activity of advanced or metastatic paraganglioma/ pheochromocytoma.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability.
  • Evidence of recent disease progression (radiological, biochemical, symptomatic).
  • Measurable disease defined as that which can be measured in at least one dimension with a minimum size of 10 mm by CT scan.
  • ECOG 0-2.
  • Life expectancy of greater than 24 weeks.
  • Age > 18 years.
  • Patients must have normal organ and marrow function.
  • Patients must have PT/INR/PTT within 1.2 X the upper limit
  • Patients may have had prior radiation therapy. A minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study.
  • Previous Surgery: Previous major surgery is permitted provided that it has been at least 28 days prior to patient registration
  • Laboratory Requirements Parameter Limit granulocytes (AGC) > 1.5 x 109/L platelets > 100 x 109/L bilirubin < 1.5XULN AST and ALT < 2.5 x ULN Amylase <1.5XULN Lipase <1.5XULN Calcium < 3 mmol/L creatinine < 2.0XULN

Exclusion Criteria:

  • History of other malignancies.
  • Patients with known brain metastases.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib.
  • Patients receiving concurrent treatment with other anti-cancer therapy given for paraganglioma or pheochromocytoma or other therapy or other investigational anticancer agents.
  • Patients who have received prior treatment with any other antiangiogenic agent or multi-targeted tyrosine kinase inhibitors are ineligible.
  • Patients with any of the following cardiovascular findings are to be excluded:
  • QTc prolongation or other significant ECG abnormalities.
  • Current or history of Class III or IV heart failure as defined by the NYHA functional classification system
  • Patients with prior anthracycline exposure, previous central thoracic radiation that included heart in radiation port, or a history of NYHA Class II cardiac function.
  • Poorly controlled hypertension
  • Myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry
  • History of venous thrombosis or pulmonary embolism in the past 3 months
  • History of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
  • Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin
  • Patients with bowel obstruction or any condition that impairs their ability to swallow and retain sunitinib tablets.
  • Use of agents with proarrhythmic potential is not permitted during the study.
  • Must be able to stop prohibited selected CYP3A4 inhibitors/inducers prior to starting sunitinib
  • Patients with pre-existing hypothyroidism prior to enrolment are ineligible unless they are euthyroid on medication.
  • Pregnant or lactating women, positive pregnancy test, women of childbearing potential who do not agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Known HIV-positive patients on combination antiretroviral therapy
  • Greater than +1 proteinuria on urinary dipstick if also >1g urinary protein/24hrs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843037

Contacts
Contact: Cristina Palmieri, B.Sc cristina.palmieri@uhn.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Principal Investigator: Dean Ruether, MD         
Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Cristina Palmieri, BSc       cristina.palmieri@uhn.ca   
Sub-Investigator: Anthony Joshua, MD         
Sub-Investigator: Shereen Ezzat, MD         
Sub-Investigator: Ian Tannock, MD         
Sub-Investigator: Monika Krzyzanowska, MD         
Principal Investigator: Jennifer Knox, MD         
Canada, Quebec
Hôpital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Principal Investigator: Isabelle Bourdeau, MD         
Sub-Investigator: Jean-Pierre Ayoub, MD         
Sub-Investigator: Karl Belanger, MD         
Sub-Investigator: Normand Blais, MD         
Sub-Investigator: Danielle Charpentier, MD         
Sub-Investigator: Bernard Lemieux, MD         
Sub-Investigator: Harold Olney, MD         
Sub-Investigator: Denis Soulieres, MD         
Sub-Investigator: Mustapha Tenfe, MD         
Sub-Investigator: Louis Yelle, MD         
Sub-Investigator: Guy Biron, MD         
Sub-Investigator: Yves Lapointe, MD         
Netherlands
University Medical Centre Groningen Recruiting
Groningen, Netherlands
Contact: Sjoukje J Oosting, MD       s.oosting@umcg.nl   
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
Principal Investigator: Jennifer Knox, MD, FRCPC University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00843037     History of Changes
Other Study ID Numbers: SNIPP
Study First Received: February 12, 2009
Last Updated: March 18, 2013
Health Authority: Canada: Health Canada
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)

Keywords provided by University Health Network, Toronto:
PARAGANGLIOMA
PHEOCHROMOCYTOMA
SUNITINIB
PHASE II
Metastatic or locally advanced malignant paraganglioma
Metastatic or locally advanced malignant pheochromocytoma

Additional relevant MeSH terms:
Pheochromocytoma
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014