Chemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002806
• Other study ID #: NCCTG-937202
• Secondary ID: CDR0000064910
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: July 1996
• Est. completion date: July 2004

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2004
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• lomustine

• procarbazine hydrochloride

• vincristine sulfate

Radiation:
• low-LET photon therapy

Locations

Country	Name	City	State
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Quain & Ramstad Clinic, P.C.	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinical and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Altru Health Systems	Grand Forks	North Dakota
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Buckner JC, Gesme D Jr, O'Fallon JR, Hammack JE, Stafford S, Brown PD, Hawkins R, Scheithauer BW, Erickson BJ, Levitt R, Shaw EG, Jenkins R. Phase II trial of procarbazine, lomustine, and vincristine as initial therapy for patients with low-grade oligoden — View Citation

Jenkins RB, Blair H, Ballman KV, Giannini C, Arusell RM, Law M, Flynn H, Passe S, Felten S, Brown PD, Shaw EG, Buckner JC. A t(1;19)(q10;p10) mediates the combined deletions of 1p and 19q and predicts a better prognosis of patients with oligodendroglioma. Cancer Res. 2006 Oct 15;66(20):9852-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Up to 5 years	No
Secondary	Disease progression		Up to 5 years	No