Trial record 2 of 22 for:    poly iclc | Open Studies

A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of California, San Diego
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Donald Durden, M.D., University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01188096
First received: August 23, 2010
Last updated: September 13, 2012
Last verified: July 2012
  Purpose

This study is for patients up to 21 years of age who have a tumor called a low grade glioma of the central nervous system (brain and spinal cord). The tumor has grown despite attempts to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that tend to grow slowly and could be cured if every bit of the tumor were surgically removed. These tumors are called Grade I or II astrocytomas.

These tumors often grow in parts of the brain that prevent total removal without devastating neurologic complications or death. Although some low grade gliomas never grow, most will and are treated with either chemotherapy or radiation. There is good data showing that the growth of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new drug that has been used safely in children and adults with different types of brain tumors. Earlier studies showed that this drug worked better for children and young adults with low grade gliomas than for children with more aggressive brain tumors. The main purpose of this study is to use Poly-ICLC treatment in a larger number of patients to see how well it works and how many side effects occur.

As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held by Oncovir.

Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments will be given in the clinic so allergic or other severe reactions, if any, can be monitored. If subjects tolerate the injections and don't have a severe reaction, then the rest of the injections will be given at home. Subjects/caregivers will be trained to give injections.

Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years if their tumor shrinks in response to the injections, if study doctors think it is safe, if subjects want to remain on treatment, and if Poly-ICLC is available.

Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study, and at higher doses. Frequently seen side effects include irritation of the skin at the injection site and mild flu-like symptoms. These are usually relieved or avoided by use of over-the-counter medicines like acetaminophen (Tylenol).


Condition Intervention Phase
Brain Tumors
Drug: Poly ICLC
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • overall response rate [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    tumor assessments are to be performed per Modified McDonald's criteria


Secondary Outcome Measures:
  • overall response rate [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    tumor assessments are to be performed per 3D measurements

  • Progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Poly ICLC
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Drug: Poly ICLC
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Other Name: Poly ICLC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age:Patients must be between 0 - 21 years of age when registered on this protocol.
  • Diagnosis:Patients must have pathologically confirmed low grade glioma with histologic subtypes interpreted as WHO grade I and II including:
  • juvenile pilocytic astrocytoma (JPA)
  • pleomorphic JPA
  • diffuse astrocytoma (fibrillary, gemistocytic, giant cell, or pleomorphic xanthoastrocytoma)
  • low grade oligoastrocytoma
  • low grade oligodendroglioma
  • low grade glioma NOS Tumors of all regions of the CNS, with appropriate histology are eligible for study. However patients with tumors intrinsic to the optic nerve and involvement of the optic nerve cannot be biopsied/resected are eligible without histological confirmation.

Patients with neurofibromatosis type 1(NF1) are also eligible.

Patients must have demonstrated either tumor progression or recurrence by radiographic criteria and/or clinical criteria as defined below:

  1. Patients with progressive non-resectable disease regardless of location in the brain or spine are eligible for this study. Patients with evidence of leptomeningeal dissemination are eligible for this study. Patients do not require biopsy/histologic confirmation at the time of progression or relapse.
  2. Radiographic progression is defined as >40% increase in the product of the three perpendicular diameters of initial tumor relative to the initial baseline measurement - length (L)x width (W) x transverse (T) (current scan) > 1.4 x L x W x T (initial scan), or the development of any new sites of disease independent of the response of the initial tumor. See section 7.1.2 for methodology for tumor measurement.
  3. Post radiation changes are often seen on post-treatment imaging studies, so that classification of a patient as having progressive disease may require several serial MRI's if the child has received radiation within the preceding 12 months.
  4. Tumor volume includes the entire tumor volume seen on gadolinium enhanced T1 MR imaging plus non-enhancing abnormality seen on T2 or FLAIR.
  5. All tumor cysts will be included in the tumor volume
  6. Clinical progression without radiographic progression includes children with optic pathway gliomas who demonstrate sustained decrease in visual fields and/or acuity in three serial vision examinations. Each of the vision examinations must be performed >2 weeks apart.
  7. Children with previously negative cerebrospinal fluid (CSF) cytology who show evidence of tumor cells in fluid obtained by lumbar puncture can be designated as having progressive disease in the absence of radiographic evidence of progression.

Measurable disease: Patients must have measurable disease documented by radiographic criteria prior to enrollment.

Performance Level and Life Expectancy:Patients must have a performance status of > 50% (Appendix I). Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age. Patients must have a life expectancy of ≥ 8 weeks.

Prior Therapy:Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet time restrictions from end of prior therapy as stated below:

  1. Myelosuppressive chemotherapy patients must have received the last dose of myelosuppressive therapy at least 3 weeks prior to study registration or at least 6 weeks if nitrosourea.
  2. Investigational / Biological agent: Patient must have received the last dose of other investigational or biological agent >7 days prior to study registration
  3. XRT: Patients must be ≥ 8 weeks since the completion of radiation therapy.
  4. Study specific limitations on prior therapy: There is no limit on the number of prior treatment regimens or received doses of radiation therapy.
  5. Growth factor(s): Must not have received any hematopoetic growth factors within 7 days of study entry or 21 days for neulasta.
  6. Prior Surgery: Must be ≥ 2 weeks from prior surgery.
  7. Steroids: Must be on a stable steroid dose for 7 days prior to study entry.

Organ Function Requirements:All patients must have adequate organ function defined as:

Hematologic Function:

  1. Hemoglobin: > 8.0 gm/dl (may transfuse PRBCs)
  2. ANC: > 750/mm3 Must be at least 7days after last dose of growth factor
  3. Platelet Count: > 50,000 (transfusion independent; ≥ 7 days from last transfusion)

Renal Function:

Serum creatinine ≤ 2 x normal for age (see below) or Creatinine clearance/GFR > 60 cc/min/1.73 m2 [Urine Creatinine (mg/dL)][Volume collected (ml)]/[Serum Creatinine 9mg/dL)][Hours x 60]

Age (years) Maximum Serum Creatinine (mg/dL)

≤ 5 0.8 > 5 & ≤ 10 1.0 > 10 & ≤ 15 1.2 > 15 1.5

Liver Function:

  1. Total bilirubin < 1.5 x ULN for age, AND
  2. SGPT (ALT) < 2.5x ULN
  3. SGOT (AST) < 2.5x ULN

Pulmonary Function:

No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry ≥ 94% if there is clinical indication for determination.

Coagulation Function:

Normal PT and PTT at enrollment per institutional range

Reproductive Function:Due to potential teratogenic effects of (poly-ICLC), negative serum beta-HCG in females, and use of effective contraception in males and females of childbearing potential, IS REQUIRED.

Exclusion Criteria:

  • Pregnant or lactating females. Women of childbearing age will agree to use contraception during the protocol.
  • Patients receiving other experimental immunotherapy.
  • Patients may not have fever (38.50C) within 7 days of enrollment.
  • No concurrent XRT or chemotherapy is allowed.
  • Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188096

Contacts
Contact: Mehrzad Mlburn 858-966-8155 mmilburn@rchsd.org
Contact: Lisa Hartman, MD 858-966-5811 lhartman@ucsd.edu

Locations
United States, California
RADY Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Mehrzad Milburn    858-966-8155    mmilburn@rchsd.org   
Contact: Lisa Hartman, MD    858-966-5811    lhartman@ucsd.edu   
Principal Investigator: Donald Durden, MD, Ph.D.         
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sindy Midoro    404-785-1441    sindy.midoro@choa.org   
Contact: Jaclyn Smith, MBA    404-785-0692    jaclyn.smith@choa.org   
Principal Investigator: Tobey MacDonald, MD         
Sponsors and Collaborators
Donald Durden, M.D.
Emory University
Investigators
Principal Investigator: Donald Durden, MD, Ph.D. University of California Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Donald Durden, M.D., Professor of Pediatrics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01188096     History of Changes
Other Study ID Numbers: Poly ICLC
Study First Received: August 23, 2010
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
glioma
pediatrics
cancer
brain tumor

Additional relevant MeSH terms:
Poly ICLC
Brain Neoplasms
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014