Chemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002806
First received: November 1, 1999
Last updated: July 7, 2015
Last verified: July 2015

November 1, 1999
July 7, 2015
July 1996
January 2003   (final data collection date for primary outcome measure)
Response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002806 on ClinicalTrials.gov Archive Site
Disease progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Chemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma
PHASE II STUDY OF PREIRRADIATION PCV CHEMOTHERAPY IN PATIENTS WITH SUPRATENTORIAL LOW-GRADE GLIOMAS

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and vincristine followed by radiation therapy in treating adults who have supratentorial glioma.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: lomustine
  • Drug: procarbazine hydrochloride
  • Drug: vincristine sulfate
  • Radiation: low-LET photon therapy
Experimental: procarbazine + lomustine + vincristine + radiation
PCV followed by external-beam cranial irradiation using at least 6 MV photons.
Interventions:
  • Drug: lomustine
  • Drug: procarbazine hydrochloride
  • Drug: vincristine sulfate
  • Radiation: low-LET photon therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2004
January 2003   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002806
NCCTG-937202, CDR0000064910
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Jan C. Buckner, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP