Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors



Status:Withdrawn
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2013
End Date:April 2014

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A Pilot Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors (I-CREST)

The purpose of this study is to use Immunochemotherapy +/- Hypofractionated Radiation for
complete response in solid tumors


Inclusion Criteria:

1. Patient has definitive histologically or cytologically confirmed metastatic NSCLC,
colon, or TNB cancer.

2. Patient has one or more metastatic tumors measurable by CT scan (or PET/CT, if
patient is allergic to CT contrast media).

3. For NSCLC patients without EGFR or ALK abnormalities amenable to EGFR or ALK targeted
therapy: patients must have received no more than at least 2 or 3 cycles of either
first- or second-line systemic therapy for the treatment of metastatic disease. For
NSCLC patients with EGFR or ALK abnormalities amenable to receive EGFR or ALK
targeted therapy: patients must have progressed on first-line EGFR or ALK targeted
therapy and received no more than at least 2 or 3 cycles of either second- or
third-line systemic therapy for the treatment of metastatic disease.

4. For colon cancer patients: patients must have patients must have received no more
than at least 2 or 3 cycles of either first- or second-line systemic therapy for the
treatment of metastatic disease.

5. For TNB cancer patients, patients must have patients must have received no more than
at least 2 or 3 cycles of either first- or second-line systemic therapy for the
treatment of metastatic disease.

6. At the time of screening, all patients must have scans (within 28 days) showing
stable disease by RECIST 1.1. Where applicable, measurable tumor marker (e.g. CA19-9,
CEA, or CA125) collected within 14 days must be at least 10% less than baseline value
on most recent systemic therapy (baseline value has to be abnormal elevated).

7. Patient has adequate biological parameters as demonstrated by the following blood
counts at time of screening:

8. Absolute neutrophil count (ANC) > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥
9 g/dL.

9. Serum creatinine ≤2.0, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit
of normal range

10. Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above
the upper limit of normal range, then a free T4 within institutional normal limits is
acceptable.

11. Persistent prior systemic therapy non-hematologic AE grade ≥2 (except alopecia or
correctable electrolyte abnormality with supplementation)

12. Patient has a Karnofsky performance status (KPS) ≥ 70.

13. Women of child-bearing potential (i.e., women who are pre-menopausal or not
surgically sterile) must be willing to use an acceptable contraceptive method
(abstinence, oral contraceptive or double barrier method) for the duration of the
study and for 30 days following the last dose of study drug, and must have a negative
urine or serum pregnancy test within 2 weeks prior to beginning treatment on this
trial.

Exclusion Criteria:

1. Active clinically serious infection > CTCAE (version 4.03) Grade 2.

2. Serious non-healing wound, ulcer, or bone fracture.

3. Patient has known brain metastases, unless previously treated and well-controlled for
at least 1 month (defined as clinically stable, no edema, no steroids and stable in 2
scans at least 4 weeks apart).

4. Inability to complete informed consent process and adhere to the protocol treatment
plan and follow-up requirements.

5. Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients
are NOT required to be tested for the presence of such viruses prior to therapy on
this protocol).

6. Requiring daily corticosteroid dose ≥ 7.5 mg prednisone or equivalent per day.

7. Patient has undergone major surgery, other than diagnostic surgery (e.g., surgery
done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks
prior to Day 1 of treatment in this study.

8. Patient has a history of allergy or hypersensitivity to any of the study drugs or any
of their excipients, or the patient exhibits any of the events outlined in the
Contraindication or Special Warnings and Precautions sections of the product or
comparator SmPC or Prescribing Information.

9. Patient has serious medical risk factors involving any of the major organ systems, or
serious psychiatric disorders, which could compromise the patient's safety or the
study data integrity.

10. Patient will be receiving any other anti-cancer therapy during participation in this
trial.
We found this trial at
1
site
Goodyear, Arizona 85338
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mi
from
Goodyear, AZ
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