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

This is an interventional supportive care trial for Grade IV Malignant Glioma focused on measuring Stem Cell, Grade IV Malignant Glioma Read More

Inclusion Criteria:

Inclusion Criteria are as follows:

1. 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).
2. Age ≥ 18 years of age.
3. Karnofsky Performance Status ≥ 60%.
4. Adequate renal function, defined as creatinine ≤ 1.3 mg/dL (μmol/L).
5. Adequate serum chemistry parameters. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ 2.5 X the ULN.
6. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
7. Women of childbearing potential must have a negative serum pregnancy test in the 48 hours prior to enrollment.
8. 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.
9. Is able to provide bone marrow sample from iliac crest.
10. Is able to return for dosing two days post bone marrow harvest for infusion at Duke University.
11. Is able to interrupt anticoagulation (if applicable) for bone marrow harvest and dosing procedures.
12. 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.
13. Patient must give written informed consent prior to any study-specific procedures being implemented.
14. Is a good candidate for the trial, in the opinion of the investigator.

Exclusion Criteria:

Exclusion Criteria are as follows:

1. Primary WHO grade IV malignant glioma (glioblastoma or gliosarcoma) with an infratentorial lesion or involvement of the spinal cord.
2. Patients with more than 1 cm of residual tumor in the maximal diameter at the post surgery MRI.
3. Pregnant or lactating females.
4. Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
5. 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.
6. History of severe allergic reaction to contrast media.
7. Any serious medical condition or psychiatric illness unresponsive to medical intervention.
8. 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.
9. Myocardial infarction in the past 3 months.
10. Mechanical heart valve.
11. Medical history or neurological pathology that prevents neurocognitive testing and prescribed patient outcome reporting.
12. Any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety and/or efficacy.
13. Current or recent history of alcohol or drug abuse.
14. Known history of infection with HIV or hepatitis.
15. Active systemic infection requiring IV antibiotics.
16. Subjects currently receiving restricted concomitant medications.
17. Any previous or current treatment with angiogenic growth factors, cytokines, gene therapy or stem cell therapy.
18. Unable to return for follow up visits for clinical evaluation, safety evaluation, laboratory studies, or MRI evaluation.
19. Inability to undergo an MRI.
20. Hemoglobin < 10g/dl.
21. Platelet counts of < 100,000 or > 700,000 at screening.
22. Hypertension with systolic BP ≥ 150mmHg or diastolic BP≥95 mmHg despite adequate anti-hypertensive treatment.
23. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.
24. Any previous or current treatment with stem cell therapy.