Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

Carmustine, Etoposide, Cytarabine, Melphalan, and Antithymocyte Globulin Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Autoimmune Neurologic Disease That Did Not Respond to Previous Therapy

Complete title: High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients with Autoimmune Neurologic Diseases

Research Study Number 2260.00
Principal Investigator George Georges, MD
Phase II

Research Study Description

This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine and melphalan together with antithymocyte globulin before a peripheral blood stem cell transplant works in treating patients with autoimmune neurologic disease that did not respond to previous therapy. In autoimmune neurological diseases, the patient's own immune system 'attacks' the nervous system which might include the brain/spinal cord and/or the peripheral nerves. Giving high-dose chemotherapy, including carmustine, etoposide, cytarabine, melphalan, and antithymocyte globulin, before a peripheral blood stem cell transplant weakens the immune system and may help stop the immune system from 'attacking' a patient's nervous system. When the patient's own (autologous) stem cells are infused into the patient they help the bone marrow make red blood cells, white blood cells, and platelets so the blood counts can improve.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: up to 70 Years (Child, Adult, Senior)

Genders Eligible for Study: Both

- Patients with an autoimmune disorder of the central or peripheral nervous system will be eligible; this will include:

-- * Primary Central Nervous System (CNS) vasculitis

-- * Rasmussen's encephalitis

-- * Autoimmune peripheral neuropathy (anti-Hu [Anna-1], anti-GM1 [GD1b], anti-MAG, anti-ganglioside, anti-sulfatide)

-- * Autoimmune cerebellar degeneration

-- * Gait Ataxia with Late age Onset Polyneuropathy (GALOP)

-- * Stiff Person Syndrome

-- * Chronic Inflammatory Demyelinating Polyneuropathy

-- * Myasthenia Gravis

-- * Lambert-Eaton myasthenic syndrome

-- * Human T-cell lymphotropic virus (HTLV)-1-associated myelopathy (HAM) / tropical spastic paraparesis (TSP)

-- * Opsoclonus / myoclonus (anti-Ri)

-- * Neuromyelitis optica

-- * Multiple sclerosis (Only patients with relapsing/remitting MS will be included)

-- * Other central or peripheral nervous system autoimmune diseases as approved by study neurologists and the Fred Hutchinson Cancer Research Center (FHCRC) faculty at Patient Care Conference (PCC)

- Patients must satisfy the criteria for a diagnosis of one of the severe neurological autoimmune disorders outlined

- Evidence of disease activity as outlined (e.g. gadolinium enhancement on magnetic resonance imaging of the brain or clinical progression)

- Patients must have failed at least 2 lines of stand therapy as outlined for the specific diseases

- DONOR: Sibling of any patient enrolled on this protocol proven by ABO typing, human leukocyte antigen (HLA) typing and variable number tandem repeat (VNTR) analysis to be syngeneic with the patient (e.g. identical twin)

- DONOR: Willing to undergo multiple apheresis procedures (except donors < 12 years who will undergo bone marrow harvests)

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Pregnancy or expressed plans to become pregnant within 1 year of the procedure

- Patients who are serologically positive for human immunodeficiency virus (HIV)

- Patients with pulmonary, cardiac, hepatic or renal impairment that would limit their ability to receive cytoreductive therapy and compromise their survival; this should include patients with any of the following:

-- * Severe pulmonary dysfunction associated with a carbon monoxide diffusing capacity (DLCO) (corrected for hemoglobin) < 60%, or requires supplemental oxygen

-- * Uncontrolled malignant arrhythmias, or clinical evidence of congestive heart failure (New York class III-IV) or ejection fraction < 50%

-- * Renal disease with estimated glomerular filtration rate (GFR) by creatinine clearance or iothalamate clearance < 50 ml/min/1.73 m^2 body surface area

-- * Serum glutamate pyruvate transaminase (SGPT)/aspartate aminotransferase (AST) > 3 times normal or direct bilirubin greater than 2.5 mg/dL on two repeated tests

- Active uncontrolled infection

- Demonstrated lack of compliance with prior medical care

- Patients whose life expectancy is limited by illness other than their neurological condition

- Patients with evidence of myelodysplasia

- Active malignancy (excluding localized squamous cell or basal cell carcinoma of the skin)

- DONOR: Inadequate documentation that donor and recipient are syngeneic

- DONOR: Donors who do not fulfill criteria as apheresis donors as established by institutional guidelines

- DONOR: Concordant for autoimmune neurological disease(s) as determined by neurological evaluation

Other exclusion criteria may apply.

Research Study Number 2260.00
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Autoimmune Diseases; Bone Marrow Transplant / Hematopoietic Stem Cell Transplant (BMT/HSCT); Central Nervous System (CNS); Myasthenia Gravis; Non-malignant Condition; Immune System Diseases

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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