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PHASE II STUDY OF PREIRRADIATION PCV CHEMOTHERAPY IN PATIENTS WITH SUPRATENTORIAL LOW-GRADE GLIOMAS


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

PHASE II STUDY OF PREIRRADIATION PCV CHEMOTHERAPY IN PATIENTS WITH SUPRATENTORIAL LOW-GRADE GLIOMAS


OBJECTIVES: I. Estimate the response rate of patients with newly diagnosed supratentorial
low-grade glioma following neoadjuvant chemotherapy with PCV
(procarbazine/lomustine/vincristine). II. Describe the toxicity of PCV. III. Determine the
incidence of disease progression in these patients during PCV treatment.

OUTLINE: The following acronyms are used: CCNU Lomustine, NSC-79037 PCB Procarbazine,
NSC-77213 PCV PCB/CCNU/VCR VCR Vincristine, NSC-67574 3-Drug Combination Chemotherapy
Followed by Radiotherapy. PCV; followed by external-beam cranial irradiation using at least
6 MV photons.

PROJECTED ACCRUAL: This study will accrue a maximum of 61 patients within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed supratentorial * grade I/II glioma,
including: Diffuse fibrillary astrocytoma No pilocytic astrocytoma No mixed tumor with
ependymoma elements * Supratentorial sites include: Frontal, temporal, parietal, or
occipital lobes Thalamus, basal ganglia, or midbrain Lateral or third ventricles Pons,
medulla, or optic chiasm tumors allowed only if secondary to eligible tumor More than 1
separate tumor allowed Diagnosis based on surgical biopsy or subtotal resection Measurable
or evaluable disease on T2-weighted MRI required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC
greater than 3,500/mm3 Platelet count greater than 130,000/mm3 Hemoglobin greater than 9
g/dL Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 2
times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 times
ULN Other: No active or uncontrolled infection No second malignancy within 3 years except:
Nonmelanomatous skin cancer In situ cervical cancer No pregnant or nursing women Negative
pregnancy test required within 7 days prior to entry Effective contraception required of
fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: At least 1 week since prior steroids OR Stable steroid
dose for at least 1 week prior to study Radiotherapy: No prior cranial or head and neck
irradiation Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jan C. Buckner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000064910

NCT ID:

NCT00002806

Start Date:

July 1996

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult diffuse astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080