Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644968
• Other study ID #: 03-066A
• Status: Completed
• Phase: Phase 1
• Start date: November 2003
• Est. completion date: April 2017

Study information

• Verified date: May 2022
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• 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

Biological:
• Tetanus Day 29
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29
• Tetanus Day 1
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
• KLH Day 1
1 mg KLH in 1 cc diluent subcutaneously on Day 1.
• KLH Day 29
1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.

Locations

Country	Name	City	State
United States	Providence Cancer Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity	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.	28 Days
Secondary	Immune Response	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.	Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.