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Phase II Study for Solid Metastatic Tumors

NCT02474186 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-08-03

No results posted yet for this study

Summary

1. To induce immunity-mediated tumor response outside the radiation field (abscopal effect) after chemo-radiation of a metastatic site in metastatic breast cancer patients.
2. To monitor the induction of a T cell response.
3. To explore the role of PET scanning to assess tumor responses/abscopal effect.

Conditions

Interventions

RADIATION

Radiation therapy

Patients with metastatic breast cancer and other metastatic solid tumors receiving single-agent chemotherapy will receive 3.5 Gy/fraction to a total dose of 35 Gy/10 fractions over 2 weeks with concurrent systemic therapy

DRUG

Xeloda

chemotherapy agent daily for two weeks

DRUG

paclitaxel

chemotherapy agent weekly for two weeks

Sponsors & Collaborators

Principal Investigators

  • Encouse Golden, M.D., Ph.D. · NYU School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2015-07-31
Completion
2015-07-31

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Entities

Drugs
Diseases
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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 NCT02474186 on ClinicalTrials.gov