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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT01644968
First received: July 17, 2012
Last updated: July 18, 2012
Last verified: July 2012

July 17, 2012
July 18, 2012
November 2003
May 2009   (final data collection date for primary outcome measure)
Dose limiting toxicity [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01644968 on ClinicalTrials.gov Archive Site
Immune Response [ Time Frame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57. ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer
Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.

This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Cancer.
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
January 2015
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01644968
03-066A
No
Providence Health & Services
Providence Health & Services
Not Provided
Principal Investigator: Brendan Curti, MD Providence Health & Services
Providence Health & Services
July 2012

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