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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
History of Changes
  Purpose

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


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Tetanus
U.S. FDA Resources

Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: November 2003
Estimated Study Completion Date: January 2015
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01644968     History of Changes
Other Study ID Numbers: 03-066A
Study First Received: July 17, 2012
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013