Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
Overview
- Phase
- Phase 1
- Intervention
- Cohort 3 anti-OX40
- Conditions
- Advanced Cancer
- Sponsor
- Providence Health & Services
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
Intervention: Cohort 3 anti-OX40
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
Intervention: Cohort 1 anti-OX40
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
Intervention: Cohort 2 anti-OX40
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
Intervention: Cohort 3 anti-OX40
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
Intervention: Tetanus Day 29
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
Intervention: Cohort 1 anti-OX40
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
Intervention: Cohort 2 anti-OX40
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
Intervention: KLH Day 1
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
Intervention: Tetanus Day 1
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
Intervention: KLH Day 29
Outcomes
Primary Outcomes
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 Outcomes
- Immune Response(Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.)