Veliparib With Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Michigan Cancer Center
Sponsor:
Information provided by (Responsible Party):
Reshma Jagsi, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01477489
First received: November 18, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to determine the maximum tolerated dose of veliparib that can be given while a patient is receiving radiation therapy.


Condition Intervention Phase
Breast Cancer
Drug: Veliparib
Radiation: Standard radiation treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Veliparib Administered Concurrently With Chest Wall and Nodal Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of veliparib that can be administered concurrently with standard doses of radiotherapy to the chest wall and regional nodes. [ Time Frame: 12-24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe the nature of toxicity that develops when PARP inhibitors are administered concurrently with chest wall radiotherapy. [ Time Frame: 12-24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Veliparib
Starting dose of veliparib will be 50 mg taken twice daily and will escalate up to a possible 200 mg twice daily.
Radiation: Standard radiation treatment
Limited to 60 Gy.

Detailed Description:

Veliparib is an investigational drug known as a "PARP inhibitor." Because veliparib affects the way that cells repair damage, veliparib may be useful in combination with radiation treatment because it may help make radiation work better. Veliparib is an oral medication that will be taken twice daily during the 6 weeks a patient is receiving radiation therapy. The researchers will also be analyzing blood and tissue taken from the skin of patients. The skin biopsies will help determine which patients are more sensitive to treatment with radiation combined with the study drug. While the blood sample will allow researchers to see if the way a person's body processes drugs affects how the patient responds to treatment.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed breast cancer with either a) locoregional recurrence after previous mastectomy or b) inflammatory breast cancer status post mastectomy for which radiotherapy to the chest wall and regional nodes is planned as part of treatment. Patients with Stage IV disease are eligible as long as they meet these criteria.
  • Surgical resection of disease and willingness to wait at least three weeks after surgery to begin radiotherapy.
  • Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies (including trastuzumab) at least two weeks prior to start of radiotherapy.
  • Age >18 years.
  • ECOG performance status <2 (Karnofsky >60%, see Appendix A).
  • Life expectancy of greater than 6 months.
  • Adequate hematologic, renal and hepatic function (assessed within the two weeks prior to registration and within the month prior to the commencement of protocol treatment).
  • Negative pregnancy test (within two weeks prior to registration) if woman has child-bearing potential (defined as not having undergone surgical methods of sterilization and having had menses within the past year).
  • Ability to swallow and retain oral medications.
  • Willingness to undergo the three required skin punch biopsies for research purposes.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Radiation therapy: Prior history of radiation therapy to the chest wall and/or regional nodes is not allowed (but prior radiation therapy to other sites is permissible).
  • Breast reconstruction: Patients who have undergone breast reconstruction procedures after mastectomy are excluded because of concerns about additional toxicity in this patient population.
  • Gross residual tumor or positive microscopic margins: Patients with gross residual tumor or positive microscopic margins will not be eligible because radiation dose in this study will be limited to 60Gy.
  • Ongoing therapy with other investigational agents: Patients may not be receiving any other investigational agents.
  • Unresolved toxicity from other agents: Patients with unresolved or unstable, CTCAE v4 Grade 3 or greater toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment are not eligible.
  • Significant comorbidity: Also ineligible are patients with clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to: active uncontrolled infection; symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib.
  • Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of any associated acute toxicities, except that endocrine therapies and bisphosphonates are permitted without restriction even during protocol treatment.
  • Pregnant women are excluded from this study because radiation therapy has teratogenic and abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with veliparib, breastfeeding should be discontinued before the patient receives veliparib.
  • Patients with active seizure disorder or history of seizure, as well as patients with CNS metastases (unless CNS metastases have been stable after therapy for >3 months and the patient is not on steroids at the time of study enrollment).
  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: NCT01477489

Contacts
Contact: Reshma Jagsi, MD 734-615-7973 rjagsi@umich.edu
Contact: Michelle Castle 734-615-8492 michcast@umich.edu

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nicole Ryabin    617-632-6767    nryabin@partners.org   
Contact: Jennifer Bellon    617-632-3591    jbellon@partners.org   
Principal Investigator: Jennifer Bellon, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Michelle Castle    734-615-8492    michcast@umich.edu   
Contact: Reshma Jagsi, MD    734-615-8492    michcast@med.umich.edu   
Principal Investigator: Reshma Jagsi, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Gina Giannantoni-Ibelli    212-639-6756    giannang@mskcc.org   
Contact: Beryl McCormick, MD    212-639-6828    mccormib@mskcc.org   
Principal Investigator: Berly McCormick, MD         
United States, North Carolina
Duke Recruiting
Durham, North Carolina, United States, 27710
Contact: Renee Welch    919-660-1278    renee.welch@duke.edu   
Contact: Janet Horton    919-660-1278    janet.horton@duke.edu   
Principal Investigator: Janet Horton, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Tanisha Davis    713-563-8698    thdavis@mdanderson.org   
Contact: Wendy Woodward    713-563-8481    wwoodward@mdanderson.org   
Principal Investigator: Wendy Woodward, MD         
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Reshma Jagsi, MD University of Michigan
  More Information

No publications provided

Responsible Party: Reshma Jagsi, MD, Associate Professor of Radiation Oncology, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01477489     History of Changes
Other Study ID Numbers: UMCC 2011.087
Study First Received: November 18, 2011
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014