- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002806
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Iowa
-
Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Sioux City, Iowa, United States, 51101-1733
- Siouxland Hematology-Oncology
-
-
Kansas
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- CCOP - Duluth
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Quain & Ramstad Clinic, P.C.
-
Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
-
Grand Forks, North Dakota, United States, 58201
- Altru Health Systems
-
-
Ohio
-
Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822-2001
- CCOP - Geisinger Clinical and Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, United States, 57105-1080
- CCOP - Sioux Community Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: procarbazine + lomustine + vincristine + radiation
PCV followed by external-beam cranial irradiation using at least 6 MV photons.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease progression
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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. doi: 10.1158/0008-5472.CAN-06-1796.
- 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 oligodendroglioma or oligoastrocytoma: efficacy and associations with chromosomal abnormalities. J Clin Oncol. 2003 Jan 15;21(2):251-5. doi: 10.1200/JCO.2003.06.023.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Vincristine
- Lomustine
- Procarbazine
Other Study ID Numbers
- NCCTG-937202
- CDR0000064910 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain and Central Nervous System Tumors
-
Children's Hospital Los AngelesUnknownBrain and Central Nervous System TumorsUnited States, Canada, Australia, Switzerland, New Zealand
-
Emory UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Duke UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Duke UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)CompletedVNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain TumorsBrain and Central Nervous System TumorsUnited States
-
St. Jude Children's Research HospitalCompletedBrain Tumors | Central Nervous System TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumors | Central Nervous System TumorsUnited States, Australia, Canada
-
University of Colorado, DenverNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
National Cancer Institute (NCI)CompletedBrain and Central Nervous System Tumors
Clinical Trials on vincristine sulfate
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Spectrum Pharmaceuticals, IncTerminatedVincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaRecurrent Adult Acute Myeloid LeukemiaUnited States
-
Nanjing Luye Sike Pharmaceutical Co., Ltd.China Medical University, China; Xijing Hospital; The Second Hospital of Hebei... and other collaboratorsUnknownAdult Acute Lymphoblastic LeukemiaChina
-
Spectrum Pharmaceuticals, IncParexelCompletedAcute Lymphoblastic Leukemia (ALL)United States, Canada, Germany, Israel, United Kingdom
-
Spectrum Pharmaceuticals, IncTerminatedAcute Lymphoblastic Leukemia (ALL)United States
-
M.D. Anderson Cancer CenterInex PharmaceuticalsCompletedSoft Tissue Sarcoma | Lymphoma | Leukemia | Osteosarcoma | Wilms' TumorUnited States
-
Antisoma ResearchCompletedProstate CancerUnited States
-
University of California, DavisGinger.ioCompletedPsychosis | Clinical High Risk for PsychosisUnited States
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI); University of California, Los Angeles; University... and other collaboratorsCompletedHuman Immunodeficiency Virus 1 Positive | AIDS-Related Kaposi SarcomaTanzania
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedIntraocular RetinoblastomaUnited States, Canada, Australia, New Zealand, India
-
National Center for Complementary and Integrative...National Institute of General Medical Sciences (NIGMS); Office of Dietary Supplements...Completed