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

Johns Hopkins Medicine

Status and phase

Completed

Phase 2

Conditions

Brain and Central Nervous System Tumors

Treatments

Drug: poly ICLC

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00058123

U01CA062399 (U.S. NIH Grant/Contract)

NABTC-0106

NABTC-0106 CDR0000287012

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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