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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058123
• Other study ID #: NABTC-0106 CDR0000287012
• Secondary ID: U01CA062399NABTC
• Status: Completed
• Phase: Phase 2
• Start date: March 7, 2003
• Est. completion date: January 2, 2009

Study information

• Verified date: July 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2, 2009
• Est. primary completion date: October 6, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

Intervention

Drug:
• poly ICLC

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Objective Response Rate (ORR)	Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.; Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.; Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.; Stable/No Response: Does not qualify for CR, PR, or progression.; Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).; ORR = CR + PR	2 years
Primary	Percentage of Participants With Progression Free Survival	Participants evaluated from date of study entry to the 6 month scan for progression	6 months
Secondary	Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas	Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0	2 years
Secondary	Overall Survival	based on date of study entry	2 years