Know Cancer

or
forgot password

A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant)


OBJECTIVES:

- Compare the overall survival and time to tumor progression in patients with anaplastic
astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs
carmustine or lomustine vs temozolomide and carmustine (arm discontinued as of
8/15/02).

- Compare the relative toxic effects of these regimens in these patients.

- Correlate molecular analyses with overall survival and time to tumor progression in
patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior
surgery (biopsy only vs resection).

Phase I (closed as of 8/15/02)

- Prior to initiating the randomization to 1 of 3 treatment arms in phase III, 15
patients are accrued to arm III. If 2 or more of the first 15 patients experience grade
3 or worse pulmonary toxicity OR if 5 or more of the first 15 patients experience grade
4-5 thrombocytopenia/neutropenia, then arm III treatment is discontinued.

Phase III

- Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive
oral temozolomide on days 1-5 of the first week of radiotherapy. Chemotherapy
repeats every 4 weeks for a total of 12 courses.

- Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV
or lomustine IV over 1-2 hours on days 1-3 of the first week of radiotherapy and a
second course on days 56-58. Chemotherapy repeats every 8 weeks for a total of 6
courses.

- Arm III (discontinued as of 8/15/02): Patients undergo radiotherapy as in arm I.
Patients receive carmustine IV or lomustine IV over 3 hours on day 5 and oral
temozolomide (2 hours after completion of carmustine or lomustine infusion) on
days 1-5 of the first week of radiotherapy. Combination chemotherapy repeats every
8 weeks for 6 courses.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I of the study and then
a total of 454 patients (227 per treatment arm) will be accrued for phase III of the study
within 4 years. (Phase I closed as of 8/15/02)

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the
following:

- Anaplastic oligoastrocytoma

- Mixed oligodendroglial/astrocytic tumors

- Oligodendroglial component must be no greater than 25%

- No vascular proliferation and necrosis

- Increased cellularity, pleomorphism, and nuclear atypia allowed

- No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum)

- Patients with prior biopsy proven low grade astrocytoma who now have anaplastic
astrocytoma and have had no prior radiotherapy or chemotherapy also eligible

- Study therapy must begin within 6 weeks of diagnosis

- No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous
meninges

- Pathologic evidence of local meningeal infiltration by underlying tumor allowed

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 1 year

Hematopoietic:

- Hemoglobin at least 10 g/dL

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3

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:

- Blood urea nitrogen no greater than 25 mg/dL

- Creatinine less than 1.5 times normal

Pulmonary:

- No pre-existing lung disease that, in the investigator's opinion, would preclude
administration of carmustine or lomustine or completion of therapy

Other:

- No other major medical illness or psychiatric impairment that would preclude study
compliance

- No other malignancy within the past 5 years except nonmelanomatous skin cancer or
carcinoma in situ of the cervix

- No known hypersensitivity to 1 of the components of carmustine, lomustine,
temozolomide, dacarbazine, or any other nitrosourea

- No active infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to brain or head and neck

Surgery:

- Not specified

Other:

- No other concurrent anticancer treatment for anaplastic astrocytoma until a
recurrence is detected

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS)

Safety Issue:

No

Principal Investigator

Susan M. Chang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000067512

NCT ID:

NCT00004259

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

Akron City HospitalAkron, Ohio  44304
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
CCOP - DuluthDuluth, Minnesota  55805
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Wesley Medical CenterWichita, Kansas  67214
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
St. John's Regional Health CenterSpringfield, Missouri  65804
Latter Day Saints HospitalSalt Lake City, Utah  84143
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Southwest Medical CenterLiberal, Kansas  67901
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
North Bay Cancer CenterFairfield, California  94533
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
John B. Amos Cancer CenterColumbus, Georgia  31904
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Guthrie Cancer Center at Guthrie Clinic SayreSayre, Pennsylvania  18840
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Enloe Cancer Center at Enloe Medical CenterChico, California  95926
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Theda Care Cancer InstituteAppleton, Wisconsin  54911
Community Memorial Hospital Cancer Care CenterMenomonee Falls, Wisconsin  53051
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Solano Radiation Oncology CenterVacaville, California  95687
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main CenterBoca Raton, Florida  33486
Florida Oncology Associates at Southside Cancer CenterJacksonville, Florida  32207
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Oncology AssociatesOrange Park, Florida  32073
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621