Phase II Study for Solid Metastatic Tumors

August 1, 2017 updated by: NYU Langone Health

Phase II Study of Chemo-Radiation-Induced Abscopal Effect in Metastatic Breast Cancer and in Other Metastatic Sites of Solid Tumors

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Eligible are women with metastatic breast cancer and patients with other metastatic solid tumors who have achieved stable disease or have disease progression after systemic therapy and have at least three separate measurable sites of disease. Extent of metastatic disease is recorded both at CT and PET scanning. Radiation is given during systemic therapy to one of the lesions, 35 Gy in ten fractions over a two week interval, conformally to maximally spare normal tissue. GM-CSF treatment is given daily for fourteen days. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with GM-CSF. Abscopal response is evaluated by assessing clinical and PET response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically confirmed breast cancer or other cancer which is persistent and metastatic or recurrent and metastatic.
  • Patients with a history of treatment for other prior malignancy will be eligible, provided they remain disease-free > 2 years after initial treatment, or were treated for non-melanoma skin cancer, or in situ cervical cancer.
  • Patients must have at least 3 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter.
  • Age >18 years.
  • ECOG performance status <2 (Karnofsky >50%).
  • Life expectancy > 3 months.

Exclusion Criteria:

  • Patients who have had immunotherapy within 4 weeks prior to entering the study.
  • Patients who have had prior allergic reaction to GM-CSF
  • Patients on steroid therapy or other immunosuppressive therapy.
  • Patients undergoing therapy with other investigational agents.
  • Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion.
  • Uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the past 6 months, unstable angina pectoris, or unstable cardiac arrhythmia requiring assessment for clinical intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Systemic agents are either capecitabine (Xeloda), paclitaxel, docitaxel or taxol
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
Other Names:
  • Radiotherapy
Drug: Xeloda
chemotherapy agent daily for two weeks
Other Names:
  • capecitabine
Drug: paclitaxel
chemotherapy agent weekly for two weeks
Other Names:
  • taxol
  • docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment.
Time Frame: week 7- week 8
week 7- week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of participants with adverse events from the date of enrollment until 12 years from the opening of the study.
Time Frame: year 0 - year 12
year 0 - year 12
The proportion of patients alive with abscopal responses from the date of enrollment until date of death from any cause, assessed up to 12 years from the opening of the study.
Time Frame: year 0- year 12
year 0- year 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Encouse Golden, M.D., Ph.D., NYU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-58

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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