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Trial record 11 of 23 for:    bavituximab

Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Elizabeth R. Gerstner, MD, Massachusetts General Hospital
Sponsor:
Collaborators:
Peregrine Pharmaceuticals
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Elizabeth R. Gerstner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03139916
First received: May 2, 2017
Last updated: June 16, 2017
Last verified: June 2017
  Purpose

This research study is studying a combination of drugs with radiation as a possible treatment for Glioblastoma.

The drugs involved in this study are:

  • Bavituximab
  • Temozolomide

Condition Intervention Phase
Glioblastoma Drug: Temozolomide Drug: Bavituximab Radiation: Radiation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma

Resource links provided by NLM:


Further study details as provided by Elizabeth R. Gerstner, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Radiographic Response [ Time Frame: every 3 months for 5 years ]
  • Progression Free Survival [ Time Frame: every 3 months for 5 years ]

Estimated Enrollment: 36
Anticipated Study Start Date: July 30, 2017
Estimated Study Completion Date: December 31, 2024
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bavituximab + Standard of Care Radiation + Temozolomide
  • Bavituximab will be administered weekly intravenously
  • Temozolomide will be administered daily
  • Standard of Care Radiation will be administered per hospital guideline.
Drug: Temozolomide
Temozolomide causes cell death and shrinks and kills the cancer cells
Other Name: Temodar
Drug: Bavituximab
Bavituximab may activate (cause) the immune system to attack the cancer cells
Radiation: Radiation
Radiation causes cell death and shrinks and kills the cancer cells.

Detailed Description:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved Bavituximab as a treatment for any disease.

The FDA has approved Temozolomide as a treatment option for this disease.

In this research study, the investigators are studying how the combination of Bavituximab, Temozolomide, and radiation affects this cancer. The current standard care of treatment for newly diagnosed glioblastoma is the combination of Temozolomide and radiation. Temozolomide causes cell death and radiation shrinks and kills the cancer cells. Bavituximab may activate (cause) the immune system to attack the cancer cells as well as target tumor cells themselves to kill them.

  Eligibility

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

Inclusion Criteria:

  • Participants must have histologically confirmed newly diagnosed glioblastoma or glioblastoma variant (ex. gliosarcoma), including documentation of unmutated isocitrate dehydrogenase (IDH) by immunohistochemistry (sequencing not required).
  • Participants must have 1-4 cm2 measurable disease (4 cm2 is the maximal size). See Section 11 for the evaluation of measurable disease. Disseminated GBM is not allowed.
  • No prior immunotherapy allowed or prior alkylating agents or prior radiation to the brain.
  • Age >17 years since adult GBM is biologically different from pediatric GBM and there is no data for bavituximab in pediatric populations.
  • Karnofsky ≥60%, see Appendix A
  • Life expectancy of greater than 6 months.
  • Participants must have normal organ and marrow function as defined below:

    • leukocytes ≥3,000/mcL
    • absolute neutrophil count ≥1,500/mcL
    • platelets ≥100,000/mcL
    • total bilirubin within normal institutional limits (unless patient has Gilbert's syndrome in which total bilirubin should be ≤ 2xULN)
    • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal(using Cockcroft Gault Formula)
    • negative serum pregnancy test in WOCBP
    • INR/PT ≤1.5 x institutional ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants
    • aPTT ≤1.5 x institutional ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants
  • < 4 mg dexamethasone daily (or equivalent if on another corticosteroid) at time of start of therapy. Patients on a steroid taper post-surgery and are anticipated to be on <4 mg at time of chemoradiation initiation will be eligible to consent but to initiate treatment on trial, the participant must be on <4 mg or equivalent of steroids otherwise participate will be deemed a screen fail and be replaced.
  • The effects of bavituximab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of bavituximab administration.
  • Able to undergo an MRI scan and receive gadolinium-based contrast.
  • 1 cm3 of available tissue.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Participants who are receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bavituximab.
  • Participants receiving any medications or substances that are moderate and/or potent enzyme inducers or inhibitors which may have an effect on the metabolism of bavituximab. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product (Appendix C for partial list).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because bavituximab is an immunotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with bavituximab breastfeeding should be discontinued if the mother is treated with bavituximab. These potential risks may also apply to other agents used in this study.
  • HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with bavituximab. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
  • Participants with other active malignancy in the past 3 years excluding in situ tumors.
  • Participants must meet the following windows from procedures (there is no window required for port placement since there is no anticipated impact on wound healing with bavituximab):

    • Major surgery (ex. craniotomy) within 3 weeks of initiation of treatment.
    • Brain biopsy within 2 weeks
  • Participants with history of bleeding disorder/coagulopathy.
  • Participants with history of chronic or acute hepatitis C or B infection
  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: NCT03139916

Contacts
Contact: Elizabeth R Gerstner, MD 617-724-8770 egerstner@mgh.harvard.edu

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Patrick Wen, MD    617-632-2166      
Principal Investigator: Patrick Wen, MD         
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth R Gerstner, MD    617-724-8770    egerstner@mgh.harvard.edu   
Principal Investigator: Elizabeth R Gerstner, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Peregrine Pharmaceuticals
National Comprehensive Cancer Network
Investigators
Principal Investigator: Elizabeth R Gerstner, MD Massachusetts General Hospital
  More Information

Responsible Party: Elizabeth R. Gerstner, MD, Principle Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03139916     History of Changes
Other Study ID Numbers: 17-037
Study First Received: May 2, 2017
Last Updated: June 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth R. Gerstner, MD, Massachusetts General Hospital:
Glioblastoma

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antibodies, Monoclonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 19, 2017