Phase 2
N=55
Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Brain and Central Nervous System Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00058123 ↗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
| Outcome | Result | p-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
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.