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A Pilot Safety Study of the Administration of Bone Marrow Derived Stem Cells (ALD-451) in WHO Grade IV Malignant Glioma

Phase 1
18 Years
Open (Enrolling)
Grade IV Malignant Glioma

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Trial Information

A Pilot Safety Study of the Administration of Bone Marrow Derived Stem Cells (ALD-451) in WHO Grade IV Malignant Glioma

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 ULN and AST ≤ 2.5 X the

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

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

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

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. Uncorrected coagulopathy as defined as INR > 1.4; PTT > 35sec.

22. Platelet counts of < 100,000 or > 700,000 at screening.

23. Hypertension with SBP ≥ 150mmHg or DBP≥95 mmHg despite adequate anti-hypertensive

24. Patients treated on any other therapeutic clinical protocols within 30 days prior to
study entry or during participation in the study.

25. Any previous or current treatment with stem cell therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of patients with unacceptable toxicity

Outcome Description:

Number of patients with irreversible Grade 3 or greater CNS toxicity or Grade 3 or greater non-hematologic toxicity if attributable to ALD -451

Outcome Time Frame:

12 months after study drug administration

Safety Issue:


Principal Investigator

Annick Desjardins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Grade IV Malignant Glioma
  • Stem Cell
  • Grade IV Malignant Glioma
  • Glioma



Duke University Medical CenterDurham, North Carolina  27710