Advanced Cancer
Conditions
Keywords
metastatic carcinoma, lymphoma, sarcoma, anti-OX40
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.
Interventions
DRUGCohort 1 anti-OX40
0.1 mg/kg anti-OX40 on days 1, 3, and 5
DRUGCohort 2 anti-OX40
.4 mg/kg anti-OX40 on days 1, 3, and 5
DRUGCohort 3 anti-OX40
2.0 mg/kg anti-OX40 on days 1, 3, and 5
BIOLOGICALTetanus Day 29
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29
BIOLOGICALTetanus Day 1
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
BIOLOGICALKLH Day 1
1 mg KLH in 1 cc diluent subcutaneously on Day 1.
BIOLOGICALKLH Day 29
1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.
Sponsors
Providence Health & Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed