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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Glen Weiss, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01936961
First received: September 3, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Metastatic Non-Small Cell Lung Cancer
Metastatic Colon Cancer
Metastatic Triple Negative Breast Cancer
Drug: CTLA-4 Antibody
Radiation: Hypofractionated Radiotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors (I-CREST)

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • Complete Response [ Time Frame: One year ] [ Designated as safety issue: No ]
    Complete response by immune-related response criteria (irRC)


Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CTLA-4 Antibody + hypofractionated radiotherapy
Hypofractionated radiotherapy completed at least 3 days prior to receipt of CTLA-4 Antibody
Drug: CTLA-4 Antibody
administered intravenously over 90 minutes every 3 weeks for a total of four doses
Radiation: Hypofractionated Radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936961

Locations
United States, Arizona
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Glen J Weiss, MD Western Regional Medical Center
  More Information

No publications provided

Responsible Party: Glen Weiss, MD, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01936961     History of Changes
Other Study ID Numbers: 13-03
Study First Received: September 3, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Western Regional Medical Center:
Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014