Clinical trial · Interventional

Phase II Study for Solid Metastatic Tumors

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

NCT02474186CI-TRIAL-00028921completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Metastatic Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78
Solid Tumor	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
paclitaxel	Drug	Paclitaxel	ALIAS
Radiation therapy	Radiation	—	UNRESOLVED
Xeloda	Drug	Capecitabine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Radiation therapy
description
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
interventionNames
1. Radiation: Radiation therapy
2. Drug: Xeloda
3. Drug: paclitaxel

Primary outcomes (1)

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

Secondary outcomes (2)

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

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 19 Years
Maximum age: 90 Years

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDGolden 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. PMID 26095785