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Completed

NCT Number: NCT01644968

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

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

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Key information

Conditions

Advanced Cancer Carcinoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Providence Cancer Center

Portland, Oregon, 97213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort 1 anti-OX40

Drug

0.1 mg/kg anti-OX40 on days 1, 3, and 5

Cohort 2 anti-OX40

Drug

.4 mg/kg anti-OX40 on days 1, 3, and 5

Cohort 3 anti-OX40

Drug

2.0 mg/kg anti-OX40 on days 1, 3, and 5

Tetanus Day 29

Biological

Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29

Other names: Tetanus Toxoid, Tetanus Toxoid Adsorbed

Tetanus Day 1

Biological

Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.

Other names: Tetansu Toxoid, Tetanus Toxoid Adsorbed.

KLH Day 1

Biological

1 mg KLH in 1 cc diluent subcutaneously on Day 1.

Other names: Immucothel.

KLH Day 29

Biological

1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.

Other names: Immucothel.

Primary outcomes

  1. 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

  1. Immune Response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2017
First posted
Jul 19, 2012
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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