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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

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Cohort 1 anti-OX40 Drug: Cohort 2 anti-OX40 Drug: Cohort 3 anti-OX40 Biological: Tetanus Day 29 Biological: Tetanus Day 1 Biological: KLH Day 1 Biological: KLH Day 29 Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
Actual Study Start Date : November 2003
Actual Primary Completion Date : May 2009
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
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: KLH Day 1
1 mg KLH in 1 cc diluent subcutaneously on Day 1.
Other Name: Immucothel.
Experimental: Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
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 1
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
Other Name: Tetansu Toxoid, Tetanus Toxoid Adsorbed.
Biological: KLH Day 29
1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.
Other Name: Immucothel.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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

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

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): NCT01644968


Locations
United States, Oregon
Providence Cancer Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Investigators
Principal Investigator: Brendan Curti, MD Providence Health & Services

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01644968     History of Changes
Other Study ID Numbers: 03-066A
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Providence Health & Services:
metastatic carcinoma
lymphoma
sarcoma
anti-OX40

Additional relevant MeSH terms:
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs