Overview

This trial is active, not recruiting.

Condition advanced cancer.
Treatments cohort 1 anti-ox40, cohort 2 anti-ox40, cohort 3 anti-ox40, tetanus day 29, tetanus day 1, klh day 1, klh day 29
Phase phase 1
Sponsor Providence Health & Services
Start date November 2003
End date May 2009
Trial size 30 participants
Trial identifier NCT01644968, 03-066A

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
cohort 1 anti-ox40
0.1 mg/kg anti-OX40 on days 1, 3, and 5
cohort 2 anti-ox40
.4 mg/kg anti-OX40 on days 1, 3, and 5
cohort 3 anti-ox40
2.0 mg/kg anti-OX40 on days 1, 3, and 5
tetanus day 29 Tetanus Toxoid, Tetanus Toxoid Adsorbed
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29
klh day 1 Immucothel.
1 mg KLH in 1 cc diluent subcutaneously on Day 1.
(Experimental)
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
cohort 1 anti-ox40
0.1 mg/kg anti-OX40 on days 1, 3, and 5
cohort 2 anti-ox40
.4 mg/kg anti-OX40 on days 1, 3, and 5
cohort 3 anti-ox40
2.0 mg/kg anti-OX40 on days 1, 3, and 5
tetanus day 1 Tetansu Toxoid, Tetanus Toxoid Adsorbed.
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
klh day 29 Immucothel.
1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.

Primary Outcomes

Measure
Dose limiting toxicity
time frame: 28 Days

Secondary Outcomes

Measure
Immune Response
time frame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
Principal investigator Brendan Curti, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Providence Health & Services.