Clinical trial NCT00058123: Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Official title: A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult anaplastic astrocytoma
adult mixed glioma
adult anaplastic oligodendroglioma
recurrent adult brain tumor
adult anaplastic ependymoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Proportion of Participants With Objective Response Rate (ORR)
timeFrame: 2 years
measure: Percentage of Participants With Progression Free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: Hillman Cancer Center at University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of California, San Francisco
name: Susan M. Chang, MD
role: STUDY_CHAIR
References:
citation: Butowski N, Lamborn KR, Lee BL, Prados MD, Cloughesy T, DeAngelis LM, Abrey L, Fink K, Lieberman F, Mehta M, Ian Robins H, Junck L, Salazar AM, Chang SM. A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas. J Neurooncol. 2009 Jan;91(2):183-9. doi: 10.1007/s11060-008-9705-3. Epub 2008 Oct 11.