NCT01644968

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

5.5 years

First QC Date

July 17, 2012

Last Update Submit

May 16, 2022

Conditions

Advanced Cancer

Keywords

metastatic carcinomalymphomasarcomaanti-OX40

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Immune Response

    Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.

Study Arms (2)

KLH + anti-OX40

EXPERIMENTAL

Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine

Drug: Cohort 1 anti-OX40Drug: Cohort 2 anti-OX40Drug: Cohort 3 anti-OX40Biological: Tetanus Day 29Biological: KLH Day 1

Tetanus vaccine + anti-OX40

EXPERIMENTAL

Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH

Drug: Cohort 1 anti-OX40Drug: Cohort 2 anti-OX40Drug: Cohort 3 anti-OX40Biological: Tetanus Day 1Biological: KLH Day 29

Interventions

Cohort 1 anti-OX40DRUG

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

KLH + anti-OX40Tetanus vaccine + anti-OX40
Cohort 2 anti-OX40DRUG

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

KLH + anti-OX40Tetanus vaccine + anti-OX40
Cohort 3 anti-OX40DRUG

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

KLH + anti-OX40Tetanus vaccine + anti-OX40
Tetanus Day 29BIOLOGICAL

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

Also known as: Tetanus Toxoid, Tetanus Toxoid Adsorbed
KLH + anti-OX40
Tetanus Day 1BIOLOGICAL

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

Also known as: Tetansu Toxoid, Tetanus Toxoid Adsorbed.
Tetanus vaccine + anti-OX40
KLH Day 1BIOLOGICAL

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

Also known as: Immucothel.
KLH + anti-OX40
KLH Day 29BIOLOGICAL

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

Also known as: Immucothel.
Tetanus vaccine + anti-OX40

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Cancer Center

Portland, Oregon, 97213, United States

Location

Related Publications (1)

  • Curti BD, Kovacsovics-Bankowski M, Morris N, Walker E, Chisholm L, Floyd K, Walker J, Gonzalez I, Meeuwsen T, Fox BA, Moudgil T, Miller W, Haley D, Coffey T, Fisher B, Delanty-Miller L, Rymarchyk N, Kelly T, Crocenzi T, Bernstein E, Sanborn R, Urba WJ, Weinberg AD. OX40 is a potent immune-stimulating target in late-stage cancer patients. Cancer Res. 2013 Dec 15;73(24):7189-7198. doi: 10.1158/0008-5472.CAN-12-4174. Epub 2013 Oct 31.

    PMID: 24177180DERIVED

MeSH Terms

Conditions

CarcinomaLymphomaSarcoma

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Brendan Curti, MD

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

November 1, 2003

Primary Completion

May 1, 2009

Study Completion

April 1, 2017

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)