Pilot Study of Bone Marrow/Stem Cells in Grade IV Malignant Glioma

Completed · Phase 1

Conditions studied: Grade IV Malignant Glioma

In brief

1\. Purpose of the Study - This protocol aims to demonstrate the feasibility and safety of autologous ALD-451 cells administered intravenously in World Health Organization (WHO) grade IV malignant glioma patients following surgery, radiation therapy and temozolomide; as well as to obtain an initial description of the effects of ALD-451 cells on neuro-cognition allowing the design of a subsequent phase 2 trial of this intervention in patients with malignant glioma. The primary objective of this study is to demonstrate the safety of intravenously administered autologous bone marrow derived ALD-451 cells in the brain following surgery, radiation therapy and temozolomide in patients with WHO grade IV malignant glioma. The secondary objective of this study is to determine the recovery of ALD-451 from bone marrow of patients following radiation therapy and temozolomide. The exploratory objective of this study is to determine if intravenous administration of autologous ALD-451 cells following surgery, radiation therapy and temozolomide in WHO grade IV malignant glioma patients may have an effect on subsequent deterioration of neurocognition and patient-reported outcomes.

Key facts

Study ID

NCT01639612

Run by

Henry Friedman

People needed

11

Starts

2012-06-01

Expected to finish

2016-04-01

Last updated by the study team

2016-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria are as follows:
• Newly diagnosed patients with histologically proven supratentorial primary WHO grade IV malignant glioma (glioblastoma or gliosarcoma) with gross total resection (less than 1 cm of residual disease in the maximal diameter).
• Age ≥ 18 years of age.
• Karnofsky Performance Status ≥ 60%.
• Adequate renal function, defined as creatinine ≤ 1.3 mg/dL (μmol/L).
• Adequate serum chemistry parameters. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ 2.5 X the ULN.
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
• Women of childbearing potential must have a negative serum pregnancy test in the 48 hours prior to enrollment.
• Men and women of reproductive potential must agree to use an effective contraceptive method including one of the following: surgical sterilization (tubal ligation for women or vasectomy for men); approved hormonal contraceptives (such as birth control pills, patches, implants or injections); barrier methods (such as condom or diaphragm) used with a spermicidal cream or an intrauterine device (IUD). Contraceptive measures such as Plan B ™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
• Is able to provide bone marrow sample from iliac crest.
• Is able to return for dosing two days post bone marrow harvest for infusion at Duke University.
• Is able to interrupt anticoagulation (if applicable) for bone marrow harvest and dosing procedures.
• Patient willing to undergo external beam radiation therapy and chemotherapy with Temozolomide at Duke University Medical Center and stay four hours post infusion of ALD-451.
• Patient must give written informed consent prior to any study-specific procedures being implemented.
• Is a good candidate for the trial, in the opinion of the investigator.

You may not qualify if…

• Exclusion Criteria are as follows:
• Primary WHO grade IV malignant glioma (glioblastoma or gliosarcoma) with an infratentorial lesion or involvement of the spinal cord.
• Patients with more than 1 cm of residual tumor in the maximal diameter at the post surgery MRI.
• Pregnant or lactating females.
• Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
• Prior chemotherapy, immunotherapy, biologic therapy, radiation therapy, radioimmunotherapy, hormonal therapy, or experimental therapy for brain tumor. Prior or active corticosteroid therapy is permitted to control neurologic symptoms due to intracranial edema.
• History of severe allergic reaction to contrast media.
• Any serious medical condition or psychiatric illness unresponsive to medical intervention.
• Prior malignancy if active treatment was required during the previous 5 years except for adequately treated basal cell or squamous cell skin cancer and in situ uterine cervical cancer.
• Myocardial infarction in the past 3 months.
• Mechanical heart valve.
• Medical history or neurological pathology that prevents neurocognitive testing and prescribed patient outcome reporting.
• Any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety and/or efficacy.
• Current or recent history of alcohol or drug abuse.
• Known history of infection with HIV or hepatitis.
• Active systemic infection requiring IV antibiotics.
• Subjects currently receiving restricted concomitant medications.
• Any previous or current treatment with angiogenic growth factors, cytokines, gene therapy or stem cell therapy.
• Unable to return for follow up visits for clinical evaluation, safety evaluation, laboratory studies, or MRI evaluation.
• Inability to undergo an MRI.
• Hemoglobin < 10g/dl.
• Platelet counts of < 100,000 or > 700,000 at screening.
• Hypertension with systolic BP ≥ 150mmHg or diastolic BP≥95 mmHg despite adequate anti-hypertensive treatment.
• Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.
• Any previous or current treatment with stem cell therapy.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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