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Trial record 27 of 77 for:    "Carotid body tumor"

Dovitinib in Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT01635907
Recruitment Status : Active, not recruiting
First Posted : July 10, 2012
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
Stephen Keefe,MD, Principal Investigator
Beth Fox, MD , Sponsor Investigator
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This study is being conducted to evaluate whether the investigational drug Dovitinib, can shrink or slow the growth of cancer in patients with certain types of neuroendocrine tumors. This study will also further evaluate the safety of this drug.

Condition or disease Intervention/treatment Phase
Advanced Metastatic Paraganglioma Advanced Metastatic Pheochromocytoma Recurrent Paraganglioma Recurrent Pheochromocytoma Unresectable Paraganglioma Unresectable Pheochromocytoma Drug: Dovitinib Phase 2

Expanded Access : Abramson Cancer Center of the University of Pennsylvania has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:
This investigator-initiated study is being conducted to evaluate whether the investigational drug, Dovitinib, can shrink or slow the growth of cancer in patients with certain types of neuroendocrine tumors (advanced malignant pheochromocytoma or paraganglioma). The primary endpoint will be response rate (Complete + Partial Response) determined by RECIST v 1.1. 25 subjects will be enrolled on this study at the University of Pennsylvania.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Dovitinib in Adults With Advanced Malignant Pheochromocytoma or Paraganglioma
Study Start Date : June 2012
Actual Primary Completion Date : March 2016





Primary Outcome Measures :
  1. Number of Adverse Events


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:

  • Patients with advanced, metastatic, recurrent or unresectable paraganglioma or pheochromocytoma. Pathology report or pathology slides (H&E) confirming histological diagnosis must be available at the time of enrollment.
  • Must have measurable disease by RECIST v1.1.
  • ECOG performance status 0, 1, 2
  • Age greater or equal to 18 years old
  • Adequate laboratory results; negative pregnancy test (females of childbearing potential)
  • Patients who give a written informed consent obtained according to institutional guidelines

Exclusion Criteria:

  • Patients with known untreated brain metastases are excluded. Patients having a history of brain metastasis that have been previously irradiated or resected greater than 3 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment.
  • Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
  • Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) less than or equal to 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have received the last administration of nitrosurea or mitomycin-C less than or equal to 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have received bevacizumab, sunitinib, sorafenib, or pazopanib less than or equal to 2 weeks prior to starting study drug, or who have not recovered (grade 1) from the side effects of these therapies.
  • Patients who have had radiotherapy less than or equal to 4 weeks prior to starting study drug, or less than or equal to 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities
  • Patients who have had therapeutic radiolabeled MIBG or other systemic radiolabeled therapy less than or equal to 4 weeks prior to starting study drug,
  • Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury less than or equal to 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
  • Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study (i.e. impaired cardiac function or clinically significant cardiac diseases, etc).
  • Pregnant or breastfeeding women or any subjects who refuse to use protocol required contraception
  • Patients unwilling or unable to comply with the protocol

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): NCT01635907


Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Stephen Keefe,MD, Principal Investigator
Beth Fox, MD , Sponsor Investigator
Investigators
Principal Investigator: Stephen Keefe, MD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01635907     History of Changes
Other Study ID Numbers: UPCC 23811
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Pheochromocytoma
Paraganglioma
Carotid Body Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Paraganglioma, Extra-Adrenal