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Breast CancerPhase 2NCT02474186

Phase II Study for Solid Metastatic Tumors

A Phase 2 study testing Radiation therapy, Xeloda and paclitaxel in people with Breast Cancer and Metastatic Breast Cancer, run by NYU Langone Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 90 years, women only
What is being tested?
Radiation therapy, Xeloda and paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
No sites listed yet
Study dates
Apr 2003to Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: 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.
Read the 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.

Being tested
Radiation therapy, Xeloda, paclitaxel
Keywords
breast, cancer, metastatic, breast cancer, metastatic breast cancer, radiation, radiotherapy, radiation therapy, abscopal, abscopal effect, T-cell, GM-CSF, anti-tumor, immune, immune response, capecitabine, xeloda, taxol, paclitaxel, other solid metastatic tumor
Medical subject headings
Breast Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation therapyRadiation

    Also called Radiotherapy

    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

  • XelodaDrug

    Also called capecitabine

    chemotherapy agent daily for two weeks

  • paclitaxelDrug

    Also called docetaxel, taxol

    chemotherapy agent weekly for two weeks

Study groups in NCT02474186
Study groupRoleWhat they receive
Radiation therapyExperimentalPatients 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
Receives: Radiation: Radiation therapy; Drug: Xeloda; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment.

    Measured: week 7- week 8

Secondary outcomes (2)

  1. The number of participants with adverse events from the date of enrollment until 12 years from the opening of the study.

    Measured: year 0 - year 12

  2. 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.

    Measured: year 0- year 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2015 (estimated)
  2. Study startApr 2003
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02474186
Sponsor's protocol ID
02-58
Status last verified
Aug 2017
First submitted
3 Jun 2015
Last updated
3 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.

    PubMed 26095785

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation therapy, Xeloda and paclitaxel in people with Breast Cancer and Metastatic Breast Cancer, run by NYU Langone Health.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment. (time frame: week 7- week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02474186, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.

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Phase II Study for Solid Metastatic Tumors | AzTrials