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Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00058123
First received: April 7, 2003
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing.

PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma.


Condition Intervention Phase
Brain and Central Nervous System 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 Patients With Recurrent Anaplastic Glioma

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression within 6 months [ Time Frame: continous, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: March 2003
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC.
  • Determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients.
  • Determine the safety profile of this drug in these patients.
  • Determine the survival of patients treated with this drug.
  • Determine the tumor response rate in patients treated with this drug.
  • Determine the biological effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed intracranial anaplastic glioma, including any of the following subtypes:

    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Other anaplastic gliomas NOTE: Patients with an original histology of low-grade glioma are allowed provided a subsequent histological diagnosis of an anaplastic glioma is made
  • Must have evidence of tumor recurrence or progression by MRI or CT scan* NOTE: *Steroid dose must be stable for at least 5 days before scan
  • Prior radiotherapy required

    • Patients who have had prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis by positron-emission tomography, thallium scanning, magnetic resonance spectroscopy, or surgical documentation of disease
  • Relapsed disease

    • Progression after initial therapy (e.g., radiotherapy with or without chemotherapy)
    • No more than 3 prior therapies (initial therapy and treatment for no more than 2 prior relapses)
    • Surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse
    • For patients who have had prior therapy for a low-grade glioma, the surgical diagnosis of high-grade glioma is considered the first relapse
  • Must be registered in the North American Brain Tumor Consortium Data Management Center database

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 8 weeks

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT less than 2 times ULN

Renal

  • Creatinine less than 1.5 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No active infection
  • No concurrent serious medical illness
  • No significant medical illness that cannot be adequately controlled with therapy or that would preclude tolerability of study drug
  • No disease that would obscure toxicity or dangerously alter drug metabolism

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 1 week since prior interferon or thalidomide
  • No prior poly ICLC

Chemotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior vincristine
  • At least 3 weeks since prior procarbazine
  • At least 6 weeks since prior nitrosoureas
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 1 week since prior tamoxifen

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Recovered from all prior therapy
  • At least 1 week since other prior noncytotoxic agents (e.g., isotretinoin), excluding radiosensitizers
  • At least 4 weeks since prior cytotoxic therapy
  • At least 4 weeks since prior investigational agents
  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: NCT00058123

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-6220
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Susan M. Chang, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00058123     History of Changes
Other Study ID Numbers: ABTC-0106 CDR0000287012, U01CA062399, ABTC-0106
Study First Received: April 7, 2003
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adult anaplastic astrocytoma
adult mixed glioma
adult anaplastic oligodendroglioma
recurrent adult brain tumor
adult anaplastic ependymoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Poly ICLC
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014