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Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects

Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; High Grade Glioma

Intervention: Dendritic Cell Vaccine (Biological); Tumor Lysate (Biological); Imiquimod (Other); Leukapheresis (Procedure)

Phase: Phase 1

Status: Recruiting

Sponsored by: Edward Ziga

Official(s) and/or principal investigator(s):
Macarena De La Fuente, MD, Principal Investigator, Affiliation: University of Miami

Summary

Dendritic Cell vaccine manufactured and partially matured using our standard operating procedures, developed in collaboration with the HGG Immuno Group, then administered through imiquimod treated skin will be safe and feasible in patients with high grade glioma. This will result in anti-tumor immunity that will prolong survival of subjects treated. Study treatment will correlate with laboratory evidence of immune activation.

Clinical Details

Official title: Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Subjects Experiencing Adverse Events

Secondary outcome:

Measurement levels of immune response before and after treatment

Overall Survival

Progression-Free Survival

Comparison of clinical outcomes to pre-treatment clinical variables measured in other DC imiquimod clinical studies.

Number of subjects with recurrent glioma who are able to receive all administrations of the Dendritic Cell Vaccine

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age: >= 13 years and < 100 years

- Relapse of high grade glioma (anaplastic astrocytoma WHO grade III or glioblastoma

multiforme WHO grade IV), histologically proven at first stage of disease (radiological evidence for recurrence suffices) or

- Relapse of glioma, which was grade II at initial diagnosis, but which is grade III or

IV at relapse based on radiological or pathological criteria

- Total or subtotal resection of tumor mass, confirmed by assessment by the

neurosurgeon and by postoperative MRI scan within 72 hours after surgery. The post-operative assessment should demonstrate residual tumor less than or equal to 2 cm3 as judged by surgeon and on MRI the tumor should only show linear contrast enhancement at the border of the resection cavity or nodule less than 2 cm3.

- No radiotherapy and/or chemotherapy received for at least 1 month before first DC

vaccination is to be administered

- No treatment with corticosteroids or salicylates for at least 1 week before first

vaccination. Corticosteroid therapy should be rapidly weaned within 1-2 weeks after surgery

- Life expectancy > 3 months

- Written consent by patient or parent(s) (if patient is < 18 years) on an

institutional review board (IRB)-approved informed consent form prior to any study-specific evaluation. Assent is required from children as per UM IRB guidelines.

- Adequate organ function (to be measured at enrollment)

- Absolute neutrophil count (ANC) >=750/L

- Lymphocytes >= 500/L

- Platelets >= 75,000/L

- Hemoglobin >= 9 g/dL

- AST/ALT =< 2. 5 X ULN; if liver metastases, =< 5 X ULN

- Serum Creatinine =< 1. 5 X ULN

- Total Bilirubin =< 3 X ULN

- Albumin > 2 g/dL

- ECOG performance status of 0 or 1 or Karnofsky > or = 70

- Subjects must agree to use adequate method of contraception or abstinence throughout

and up to 4 weeks after the study treatment completion.

- Capable of understanding the investigational nature, potential risks and benefits of

the study and able to provide valid informed consent. Exclusion Criteria:

- Pregnancy

- Breast feeding females

- Any concomitant participation in other therapeutic trials

- Virus serology positive for HIV(testing is not required in the absence of clinical

suspicion)

- Documented immunodeficiency

- Documented autoimmune disease

- Mandatory treatment with corticosteroids or salicylates in the week prior to first

vaccination

- Other active malignancies

- Patients with unresectable tumors, for instance pontine gliomas, are excluded.

- Refusal to use adequate contraception for fertile patients (females and males) during

the study and for 30 days after the last dose of study treatment.

- Any serious or uncontrolled medical or psychiatric condition that in the opinion of

the investigator makes the patient not able to participate in the study.

- Application of gliadel wafers within the prior 4 months or a plan to place gliadel

wafers at the time of resection for tumor acquisition for study

Locations and Contacts

University of Miami, Miami, Florida 33136, United States; Recruiting
Macarena De La Fuente, MD, Email: mdelafuente@med.miami.edu
Emil Kamar, Email: e.kamar@med.miami.edu
Ofelia Alvarez, MD, Sub-Investigator
Martin Andreasky, MD, PhD, Sub-Investigator
Antonello Podda, MD, Sub-Investigator
Julio Barredo, MD, Sub-Investigator
Joanna Davis, MD, Sub-Investigator
Deborah Heros, MD, Sub-Investigator
Edward D Ziga, MD, Sub-Investigator
Sherry Shariatmadar, MD, Sub-Investigator
Fernando Corrales, MD, Sub-Investigator
Macarena De La Fuente, MD, Principal Investigator
Additional Information

Starting date: July 2013
Last updated: July 14, 2015

Page last updated: August 23, 2015

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