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Trial record 2 of 2 for:    klh | First posted from 06/01/2012 to 08/16/2012

Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT01644968
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Providence Health & Services

Tracking Information
First Submitted Date  ICMJE July 17, 2012
First Posted Date  ICMJE July 19, 2012
Last Update Posted Date June 15, 2017
Actual Study Start Date  ICMJE November 2003
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
Dose limiting toxicity [ Time Frame: 28 Days ]
A dose limiting toxicity is defined as any grade >=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
Immune Response [ Time Frame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57. ]
Blood tests and leukapheresis product will be collected to determine the response to three types of reporter antigens: (1) new antigen (keyhole limpet hemocyanin (KLH)), (2) recall protein antigen (tetanus), and (3) viral antigen (cytomegalovirus (CMV)). Changes in the number of antigens will be used to determine immune response.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer
Official Title  ICMJE Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
Brief Summary This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.
Detailed Description This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Drug: Cohort 1 anti-OX40
    0.1 mg/kg anti-OX40 on days 1, 3, and 5
  • Drug: Cohort 2 anti-OX40
    .4 mg/kg anti-OX40 on days 1, 3, and 5
  • Drug: Cohort 3 anti-OX40
    2.0 mg/kg anti-OX40 on days 1, 3, and 5
  • Biological: Tetanus Day 29
    Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29
    Other Name: Tetanus Toxoid, Tetanus Toxoid Adsorbed
  • Biological: Tetanus Day 1
    Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
    Other Name: Tetansu Toxoid, Tetanus Toxoid Adsorbed.
  • Biological: KLH Day 1
    1 mg KLH in 1 cc diluent subcutaneously on Day 1.
    Other Name: Immucothel.
  • Biological: KLH Day 29
    1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.
    Other Name: Immucothel.
Study Arms  ICMJE
  • Experimental: KLH + anti-OX40
    Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
    Interventions:
    • Drug: Cohort 1 anti-OX40
    • Drug: Cohort 2 anti-OX40
    • Drug: Cohort 3 anti-OX40
    • Biological: Tetanus Day 29
    • Biological: KLH Day 1
  • Experimental: Tetanus vaccine + anti-OX40
    Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
    Interventions:
    • Drug: Cohort 1 anti-OX40
    • Drug: Cohort 2 anti-OX40
    • Drug: Cohort 3 anti-OX40
    • Biological: Tetanus Day 1
    • Biological: KLH Day 29
Publications * Curti BD, Kovacsovics-Bankowski M, Morris N, Walker E, Chisholm L, Floyd K, Walker J, Gonzalez I, Meeuwsen T, Fox BA, Moudgil T, Miller W, Haley D, Coffey T, Fisher B, Delanty-Miller L, Rymarchyk N, Kelly T, Crocenzi T, Bernstein E, Sanborn R, Urba WJ, Weinberg AD. OX40 is a potent immune-stimulating target in late-stage cancer patients. Cancer Res. 2013 Dec 15;73(24):7189-7198. doi: 10.1158/0008-5472.CAN-12-4174. Epub 2013 Oct 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2012)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.
  • ECOG performance status 0, 1, 2
  • No active bleeding
  • No clinical coagulopathy
  • Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

  • Active residual toxicity from prior therapies
  • Active Infection
  • HIV positive
  • Hepatitis B or C positive
  • Pregnant or nursing women
  • Requirement for oral steroids
  • Brain metastases
  • Presence or history of autoimmune disease
  • Shellfish or tetanus allergy
  • Splenomegaly
  • Lymph nodes greater than 10 cm in maximal diameter
  • Uncontrolled angina or class II or IV heart failure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01644968
Other Study ID Numbers  ICMJE 03-066A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Providence Health & Services
Study Sponsor  ICMJE Providence Health & Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brendan Curti, MD Providence Health & Services
PRS Account Providence Health & Services
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP