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Anti-OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer

NCT01303705 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-08-29

No results posted yet for this study

Summary

This clinical trial will examine a novel combination of anti-OX40 to induce proliferation of memory and effector T cells in conjunction with cyclophosphamide (CTX) and radiation to induce tumor antigen release with the overall goal of promoting an immune response against prostate cancer.

Conditions

Interventions

DRUG

Anti-OX40

Anti-OX40 will be administered intravenously at 0.4 mg/kg on days 4, 6 and 8 of the study. The total anti-OX40 dose will be reconstituted in 100 ml 0.9% saline and infused over no more than 60 minutes intravenously. A single-use non-pyrogenic durapore membrane low protein binding filter (e.g.: Braun 1.2 micron air eliminating filter or equivalent) shall be used to filter the study product in the line between infusion bag and patient.

RADIATION

Radiation

8.0 Gy in 1 fraction to a maximum of three bone metastatic deposits will be administered on Day 4 of treatment. Imaging such as bone scan, MRI, CT scan, or radiograph must identify the target lesion as consistent with metastatic disease. Any bone lesion that is inducing pain or where there may be a clinical concern for potential pathological fracture will be selected over asymptomatic lesions.

DRUG

Cyclophosphamide

CTX will be administered on day 1 (Friday only) at a dose determined by cohort assignment. The drug should be diluted per institutional standards. An added dose of IV fluids may help prevent bladder toxicity. In this protocol, CTX will be administered intravenously over 30 - 60 minutes.

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Brendan D Curti, MD · Providence Health & Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-14
Primary Completion
2016-07-05
Completion
2016-07-05

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303705 on ClinicalTrials.gov