Overview

Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells Administered to Patients With Brain Tumors

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study involves cancer research and the purpose is to assess the safety and activity of a type of vaccine as immune therapy for cancer. This vaccine will be made from each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells (DCs) are immune cells whose role is to identify foreign material in the body (such as bacteria, viruses, or tumor cells). When DCs recognize this material, they use it to activate other cells of the immune system to mount an attack against that foreign material. In the Laboratory of Molecular Neuro-Oncology, each participant's DCs will be loaded with samples of their own tumor cells that were obtained at surgical resection. These tumor cells are killed in the laboratory using a special protocol, and then "fed" to the DCs. The DCs "eat" this material, and these "fed" DCs make up the vaccine.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rockefeller University
Collaborator:
Memorial Sloan Kettering Cancer Center
Treatments:
Vaccines
Criteria
Inclusion Criteria:

Screening to determine eligibility (with the exception of HLA haplotyping) will be
completed within 45 days fo study entry.

1. Disease Characteristics

Histologically confirmed brain cancers, reviewed at MSKCC. Pathologic examination will
be of surgical resection specimens deemed of suitable quality for definitive diagnosis
by the histopathologist.

Primary Brain Tumors:

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Anaplastic oligodendroglioma

- Malignant mixed oligoastrocytoma

Secondary (metastatic) brain tumors - newly diagnosed or recurrent disease

- All histological grade of disease accepted

Surgically accessible tumor for which resection is indicated. Tumors may be from
initial resections or re-resections. Recovery of a minimum of 1x10^7 tumor cells ex
vivo is required.

Patients with primary brain tumors must have been previously treated with conventional
therapy.

2. Prior/Concurrent Therapy

1. Recovered from toxicity of any prior therapy

2. Biologic Therapy

- No concurrent other immunotherapy and no prior immunotherapy with any of the
components of the current regimen (autologous DCs, cancer cells, or KLH)

3. Chemotherapy:

- No concurrent immunomodulatory or chemotherapy therapy

- Chemotherapy, including temozolomide and local chemotherapies such as
Gliadel Wafers, must be deferred until after last post-vaccine leukapheresis

4. Endocrine evaluation/therapy:

- steroid dose no greater than 1mg daily dexamethasone (or equivalent)

5. Radiotherapy:

- No concurrent brain radiation

6. Surgery:

- Surgical resection must have been completed independently of this study, and
suitable samples obtained for vaccine production

3. Patient Characteristics

1. Age: 18 and over, able to give written informed consent. May be obtained through
use of legal representation such as a health care proxy

2. Performance status: Karnofsky 60-100%

3. Life expectancy: at least 4-6 months

4. Hematopoietic:

- WBC greater than 3,800

- Absolute lymphocytes greater than 500

- Absolute neutrophil counter great than 1,500/mm^3

- Platelets greater than 100,000/mm^3

- Hb greater than or equal to 10g/dL

5. Hepatic: bilirubin less than 2mg/dL OR SGOT less than 2x ULN

6. Renal: Creatinine no greater than 2mg/dL

7. Cardiovascular:

- No NYHA class III/IV status

- No active angina, uncontrolled clinically significant cardiac arrythmia,
recent (6 months) myocardial infarction

8. Pulmonary: No symptomatic pulmonary disease or pulse oximetry less than 93% on
room air

9. Endocrine: No history of autoimmune thyroid disease

10. Radiographic: baseline contrast-enhanced MRI or CT scan of brain post surgical
resection

11. Coagulation: No unexplained INR >2

Exclusion criteria:

- No active infection requiring antibiotics

- No history of HIV, hepatitis B or hepatitis C virus infection, no history of high risk
behavior for such infection (intravenous drug abuse, men having unprotected sex with
men). Laboratory evaluation for HIV, hepatitis B, hepatitis C to be obtained prior to
study entry

- No history of hypersensitivity to vaccine components

- No history of autoimmune or vasculitic disease (including but not limited to systemic
lupus erythematosis, Hashimoto's thyroiditis, rheumatoid arthritis, systemic
necrotizing vasculitides (polyarteritis nodosa group), hypersensitivity vasculitis,
Wegener's granulomatosis), scleroderma, multiple sclerosis, juvenile-onset
insulin-dependent diabetes

- No medical or psychiatric illness or social condition that, in the opinion of the
investigator, would interfere with adherence to study requirements

- No alcohol or drug use or dependence that, in the opinion of the investigator, would
interfere with adherence to study requirements