Phase II Study for Solid Metastatic Tumors

NCT02474186 | Completed Phase 2 DMC

• 1 other identifier: 02-58
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.To monitor the induction of a T cell response.
3. 3.To explore the role of PET scanning to assess tumor responses/abscopal effect.

Conditions

Breast Cancer; Metastatic Breast Cancer; Solid Tumor

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

Outcome Measures

Primary Outcomes (1)

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

  week 7- week 8

Secondary Outcomes (2)

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

  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.

  year 0- year 12

Study Arms (1)

Radiation therapy

EXPERIMENTAL

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; Drug: Xeloda; Drug: paclitaxel

Interventions

Radiation therapy RADIATION

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

Also known as: Radiotherapy

Radiation therapy

Xeloda DRUG

chemotherapy agent daily for two weeks

Also known as: capecitabine

Radiation therapy

paclitaxel DRUG

chemotherapy agent weekly for two weeks

Also known as: docetaxel, taxol

Radiation therapy

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Related Publications (1)

• 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.

  PMID: 26095785 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Radiotherapy; Capecitabine; Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Encouse Golden, M.D., Ph.D.

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 17, 2015
• Study Start: April 1, 2003
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 3, 2017

Record last verified: 2017-08