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

• ClinicalTrials.gov Identifier: NCT00058123
• Recruitment Status: Completed
• First Posted: April 9, 2003
• Results First Posted: August 21, 2018
• Last Update Posted: August 21, 2018
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information

• First Submitted Date: April 7, 2003
• First Posted Date: April 9, 2003
• Results First Submitted Date: October 14, 2016
• Results First Posted Date: August 21, 2018
• Last Update Posted Date: August 21, 2018
• Actual Study Start Date: March 7, 2003
• Actual Primary Completion Date: October 6, 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2018)

• Proportion of Participants With Objective Response Rate (ORR) [ Time Frame: 2 years ]
  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
• Percentage of Participants With Progression Free Survival [ Time Frame: 6 months ]
  Participants evaluated from date of study entry to the 6 month scan for progression

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: July 24, 2018)

• Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas [ Time Frame: 2 years ]
  Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
• Overall Survival [ Time Frame: 2 years ]
  based on date of study entry

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Brain and Central Nervous System Tumors
• Intervention: Drug: poly ICLC

Study Arms

Experimental: Poly-ICLC Recurrent gliomas

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

Drug Poly-ICLC

Intervention: Drug: poly ICLC

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 24, 2018): 55
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 2, 2009
• Actual Primary Completion Date: October 6, 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00058123
• Other Study ID Numbers: NABTC-0106 CDR0000287012; U01CA062399 ( U.S. NIH Grant/Contract ); NABTC-0106
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Study Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Susan M. Chang, MD; University of California, San Francisco

• PRS Account: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Verification Date: July 2018