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Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma

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ClinicalTrials.gov Identifier: NCT00107185
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE April 5, 2005
First Posted Date  ICMJE April 6, 2005
Last Update Posted Date August 5, 2020
Study Start Date  ICMJE January 2005
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
survival [ Time Frame: 1 year ]
survival with this vaccine
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 2, 2012)
time to progression [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
Official Title  ICMJE Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas in Pediatric Patients
Brief Summary

RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery may be a more effective treatment for malignant glioma.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma.

Detailed Description

OBJECTIVES:

Primary

  • Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
  • Determine the maximum tolerated dose of this vaccine in these patients.

Secondary

  • Determine, preliminarily, the survival of patients treated with this vaccine.
  • Determine, preliminarily, the time to tumor progression in patients treated with this vaccine.
  • Determine cellular immune response in patients treated with this vaccine.
  • Determine age-dependent differences in response to this vaccine, in terms of immunocompetence, in these patients.

OUTLINE: This is a dose-escalation study.

Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) for generation of dendritic cells (DC). DC are pulsed with tumor lysate to produce an autologous dendritic cell vaccine. Approximately 10-30 days after leukapheresis, patients receive vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 2 weeks and then every 2 months for 1 year.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2-4.5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE Biological: therapeutic autologous dendritic cells
Study Arms  ICMJE Experimental: Vaccine
Intervention: Biological: therapeutic autologous dendritic cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2012)
7
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed* WHO grade III or IV malignant glioma of 1 of the following subtypes:
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme NOTE: *Must be confirmed after surgery
  • Newly diagnosed OR recurrent disease
  • Bidimensionally measurable disease by contrast-enhancing pre-operative MRI
  • Surgically accessible tumor for which surgical resection is indicated at the time of initial pre-operative evaluation
  • Must have undergone standard surgery* AND either radiotherapy* or chemoradiotherapy*
  • Objective evidence of disease by contrast-enhanced brain MRI after completion of standard therapy NOTE: *Completed after study entry but before assignment to study treatment cohorts
  • Age 1 to 18
  • Performance status Karnofsky 60-100%
  • Hematopoietic

    • Hemoglobin ≥ 10 g/dL
    • Absolute granulocyte count ≥ 1,500/mm^3
    • Platelet count ≥ 100,000/mm^3
  • Hepatic

    • SGPT and SGOT ≤ 2 times normal
    • Alkaline phosphatase ≤ 2 times normal
    • Bilirubin ≤ 1.5 mg/dL
    • Hepatitis B and C negative
  • Renal

    • BUN ≤ 1.5 times normal OR
    • Creatinine ≤ 1.5 times normal
  • Immunologic

    • HIV negative
    • Syphilis negative
  • At least 2 weeks since prior radiotherapy and recovered
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No chemotherapy during and for 4 weeks* after the final dose of study vaccine
  • No corticosteroids for at least 10 days before leukapheresis
  • No concurrent corticosteroids
  • More than 72 hours since prior systemic antibiotics
  • No antihistamines for 5 days before and for 5 days after administration of study vaccine

Exclusion Criteria:

  • history of immunodeficiency or autoimmune disease that may be exacerbated by immunotherapy, including any of the following:
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Vasculitis
  • Polymyositis
  • Dermatomyositis
  • Scleroderma
  • Multiple sclerosis
  • Juvenile-onset insulin-dependent diabetes
  • active infection
  • fever
  • allergy to study reagents
  • pregnant or nursing
  • other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix
  • unstable or severe medical or psychiatric condition, as determined by the investigator
  • underlying condition that would preclude study participation
  • concurrent radiotherapy
  • prior organ allograft
  • concurrent strong painkillers
  • other concurrent immune-suppressing medications
  • other concurrent investigational agents
  • other adjuvant treatment for 4 weeks* after the final dose of study vaccine NOTE: *Unless there is evidence of tumor progression necessitating additional clinically-indicated treatment; patients requiring treatment due to tumor progression are removed from the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00107185
Other Study ID Numbers  ICMJE CDR0000420930
UCLA-0410044-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph L. Lasky, MD Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP