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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression within 6 months

Outcome Time Frame:

continous, 6 months

Safety Issue:

No

Principal Investigator

Susan M. Chang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

ABTC-0106 CDR0000287012

NCT ID:

NCT00058123

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • adult anaplastic oligodendroglioma
  • recurrent adult brain tumor
  • adult anaplastic ependymoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781