CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
poly ICLCdrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically confirmed intracranial anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or other anaplastic gliomas)
  • ✓Evidence of tumor recurrence or progression by MRI or CT scan (with stable steroid dose for at least 5 days before scan)
  • ✓Prior radiotherapy required; for prior brachytherapy or stereotactic radiosurgery, must have confirmation of true progressive disease rather than radiation necrosis
  • ✓Relapsed disease: progression after initial therapy (radiotherapy with or without chemotherapy); no more than 3 prior therapies total
Key exclusion· 6
  • ✕Prior poly ICLC therapy
  • ✕Other cancer within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of cervix
  • ✕Active infection
  • ✕Concurrent serious medical illness or significant medical illness that cannot be adequately controlled with therapy or that would preclude tolerability of study drug

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00058123
NCT00058123Phase 2Completed
CompareCT.gov

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Apr 9, 2003·Updated Aug 21, 2018

In Brief

A Phase 2 clinical trial evaluating poly ICLC for Brain and Central Nervous System Tumors. Completed, enrolled 55 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain and Central Nervous System Tumors
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartMar 7, 2003
Primary CompletionOct 6, 2007
Study CompletionJan 2, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 23.2 years ago

Interventions

poly ICLCdrug