Mode
Text Size
Log in / Sign up
Phase 2 N=55 Treatment

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

Brain and Central Nervous System Tumors

Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Proportion of Participants With Objective Response Rate (ORR) — 5 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
poly ICLC (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary completion
Oct 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Participants With Objective Response Rate (ORR)
5
PRIMARY
Percentage of Participants With Progression Free Survival
24
SECONDARY
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
1; 4; 1; 2; 1; 1
SECONDARY
Overall Survival
43

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00058123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search