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A Phase I Study of Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells (DC/AAT) Administered Intradermally to Cancer Patients With Brain Tumors

Phase 1
18 Years
Open (Enrolling)
Brain Tumors

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Trial Information

A Phase I Study of Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells (DC/AAT) Administered Intradermally to Cancer Patients With Brain Tumors

If you are eligible, and you decide to join this research study, you will get two to three
shots of the experimental vaccine, each three weeks apart.

You will then have a follow up period where we will monitor you and your medical records for
any affects of the experimental treatment.

Inclusion Criteria

Inclusion/ Exclusion 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

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

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

11. Coagulation: No unexplained INR >2

12. Other:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Toxicity- assessment of safety and tolerability

Outcome Time Frame:

week 0 to week 9

Safety Issue:


Principal Investigator

Robert Darnell, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rockefeller University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • Brain Tumors
  • Brain Neoplasms



Rockefeller University New York, New York  10021