Phase II Study for Solid Metastatic Tumors

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Docetaxel; Paclitaxel

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.