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Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System


Phase 2
N/A
N/A
Not Enrolling
Both
Glioblastoma

Thank you

Trial Information

Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System


To become eligible for therapy the following criteria must be fulfilled:

- No age or gender limit

- Patients with atypical malignant brain tumors.

- Must have a Karnofsky performance of at least 60%

- Hematologic studies and chemistry profiles will be within the parameters of the
protocol

- Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide
must be generated in sufficient quantity and patient must have no prior sensitivity to
the components of the dendritic cell vaccine.

- Patients are excluded if they have systemic disease, presence of acute infection, known
history of autoimmune disorder and pregnancy.


Inclusion Criteria:



- No age or gender limit, though minimal weight limitations for apheresis is about 15 -
20 Kg.

- Both male and female of childbearing age entering the protocol must use a medically
accepted form of birth control during the study, will be required to have a negative
pregnancy test for female.

- patients with atypical malignant brain tumor will be eligible.

- Patients must have a Karnofsky performance score of at least 60%

- patients may be maintained on glucocorticoid therapy at the lowest possible dose.

- Baseline hematologic studies and chemistry profiles must meet the criteria.

- Tumor specimen of adequate size to yield protein concentration in sufficient
quantity.

- Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for
vaccination.

- Patient must have no prior sensitivity to the components of the dendritic cell
vaccine.

- Patient must agree to consider an autopsy in the event of death in an attempt to
learn more concerning the nature of this treatment and tumor biology.

- Patient must be capable of signing IRB approved Research Consent and Release of
medical Records form.

Exclusion Criteria:

- Severe pulmonary, cardiac or other systemic disease associated with an unacceptable
anesthetic or operative risk.

- The presence of an acute infection requiring active treatment will be criteria for
delay or exclusion.

- Patients with a known history of an autoimmune disorder.

- Inability to give informed consent.

- Pregnancy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

John Yu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

3368

NCT ID:

NCT00576537

Start Date:

March 2001

Completion Date:

October 2011

Related Keywords:

  • Glioblastoma
  • New/Recurrent Glioblastoma
  • Brain Neoplasms
  • Glioblastoma
  • Central Nervous System Neoplasms

Name

Location

Cedars Sinai Medical Center Los Angeles, California  90048-1804