Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer
- Conditions
- Advanced Cancer
- Interventions
- Drug: Cohort 1 anti-OX40Drug: Cohort 2 anti-OX40Drug: Cohort 3 anti-OX40Biological: Tetanus Day 29Biological: Tetanus Day 1Biological: KLH Day 1Biological: KLH Day 29
- Registration Number
- NCT01644968
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KLH + anti-OX40 Cohort 1 anti-OX40 Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine KLH + anti-OX40 Cohort 2 anti-OX40 Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine KLH + anti-OX40 Cohort 3 anti-OX40 Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine KLH + anti-OX40 Tetanus Day 29 Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine KLH + anti-OX40 KLH Day 1 Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine Tetanus vaccine + anti-OX40 Cohort 1 anti-OX40 Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH Tetanus vaccine + anti-OX40 Cohort 2 anti-OX40 Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH Tetanus vaccine + anti-OX40 Cohort 3 anti-OX40 Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH Tetanus vaccine + anti-OX40 Tetanus Day 1 Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH Tetanus vaccine + anti-OX40 KLH Day 29 Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
- Primary Outcome Measures
Name Time Method Dose limiting toxicity 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
Name Time Method Immune Response 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.
Trial Locations
- Locations (1)
Providence Cancer Center
🇺🇸Portland, Oregon, United States