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Phase II Study for Solid Metastatic Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474186
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Breast Cancer Solid Tumor Radiation: Radiation therapy Drug: Xeloda Drug: paclitaxel Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Chemo-Radiation-Induced Abscopal Effect in Metastatic Breast Cancer and in Other Metastatic Sites of Solid Tumors
Study Start Date : April 2003
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

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 Name: Radiotherapy

Drug: Xeloda
chemotherapy agent daily for two weeks
Other Name: capecitabine

Drug: paclitaxel
chemotherapy agent weekly for two weeks
Other Names:
  • docetaxel
  • taxol




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

Secondary Outcome Measures :
  1. 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 ]
  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. [ Time Frame: year 0- year 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474186


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Encouse Golden, M.D., Ph.D. NYU School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02474186     History of Changes
Other Study ID Numbers: 02-58
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

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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
Keywords provided by NYU Langone Health:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites