Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02541370 : Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART133
PhasePhase 1
AgesMin: 18 Years Max: 70 Years
Eligibility
Inclusion Criteria:

1. Chemotherapy refractory or relapsed CD133-positive liver cancer, pancreatic cancer,
brain tumor ,breast cancer, ovarian tumors, colorectal cancer and acute leukemia.

2. Patients must be 18 years of age or older.

3. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of
0-2.

4. Patients must have evidence of adequate bone marrow reserve, hepatic and renal
function as evidenced by the following laboratory parameters:

Absolute neutrophil count greater than 1500/mm3. Platelet count greater than
100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet
this parameter).

Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or
equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m.

5. Seronegative for HIV antibody.

6. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.

7. Patients must be willing to practice birth control during and for four months
following treatment. NOTE: women of child-bearing age must have evidence of negative
pregnancy test.

8. Patients must be willing to sign an informed consent.

Exclusion Criteria:

- 1. Patients with life expectancy less than 12 months will be excluded. 2. Patients
with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by
uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (>
New York Heart Association Class II), or myocardial infarction within 6 months of
study will be excluded.

3. Patients with any of the following pulmonary function abnormalities will be
excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of
lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation
less than 90% on room air.

4. Patients with severe liver and kidney dysfunction or consciousness disorders will
be excluded.

5. Pregnant and/or lactating women will be excluded. 6. Patients with active
infections, including HIV, will be excluded, due to unknown effects of the vaccine on
lymphoid precursors.

7. Patients with any type of primary immunodeficiencies will be excluded from the
study.

8. Patients requiring corticosteroids (other than inhaled) will be excluded. 9.
Patients with history of T cell tumors will be excluded. 10. Patients who are
participating or participated any other clinical trials in latest 30 days will be
excluded.

11. Patients with relapsed acute leukemia after allogeneic stem cell transplantation
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02541370      |      Link to official Clinicaltrials.gov listing
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