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A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

Thank you

Trial Information

A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases


OBJECTIVES:

- Compare the median survival time in patients with brain metastases after receiving
treatment with whole brain radiotherapy with or without RSR13.

- Compare the response rate to these treatment regimens in these patients.

- Compare the time to progression after receiving these treatment regimens in these
patients.

- Compare quality of life in these patients receiving these treatment regimens.

- Compare cause of death (neurologic vs nonneurologic death) in these patients after
receiving these treatment regimens.

- Determine the safety of RSR13 in these patients.

- Assess the pharmacokinetics of RSR13 in these patients.

OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are
stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients
are further stratified within the RPA class II stratum according to site of primary cancer
(non-small cell lung cancer vs breast vs other). Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in
conjunction with supplemental oxygen breathing.

- Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy
and supplemental oxygen breathing as in arm I.

Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months,
and then every 3 months until disease progression.

Patients are followed at 1 month, 3 months, every 3 months until disease progression, and
then for survival.

PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for
this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Radiographically, histologically, or cytologically confirmed brain metastases with
histologically or cytologically confirmed primary malignancy except the following:

- Small cell lung cancer, germ cell tumors, and lymphomas

- No leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 10 g/dL

- WBC at least 2,000/mm3

- Platelet count at least 75,000/mm3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- ALT and AST no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Pulmonary:

- Forced vital capacity and forced expiratory volume at least 50% of normal in patients
with significant intrathoracic tumor involvement, chronic obstructive pulmonary
disease, interstitial lung disease, or pulmonary embolism

- Resting and exercise oxygen saturation at least 90% on room air

Other:

- No other concurrent active malignancy from a second histologic site

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy or immunotherapy for brain metastases

- At least 28 days since prior investigational biologic therapy

Chemotherapy:

- No prior chemotherapy for brain metastases

- No chemotherapy for brain metastases for at least one month following radiation
therapy

- At least 7 days since prior chemotherapy for primary tumor or extracranial metastases

- No planned chemotherapy during radiation therapy

Endocrine therapy:

- No prior hormonal therapy for brain metastases

- Prior or concurrent corticosteroid therapy allowed

Radiotherapy:

- No prior whole brain radiotherapy for brain metastases

- No prior stereotactic radiosurgery for brain metastases

Surgery:

- Prior surgery allowed for brain metastases if at least one measurable lesion remains

Other:

- At least 28 days since prior investigational drug or device

- No prior RSR13

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Edward G. Shaw, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000067957

NCT ID:

NCT00005887

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Akron City HospitalAkron, Ohio  44304
Arizona Cancer CenterTucson, Arizona  85724
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Colorado Cancer CenterDenver, Colorado  80262
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
Harbor Hospital CenterBaltimore, Maryland  21225
Akron General Medical CenterAkron, Ohio  44302
Massey Cancer CenterRichmond, Virginia  23298-0037
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Ochsner ClinicNew Orleans, Louisiana  70121
California Cancer Care, Inc.Greenbrae, California  94904-2007
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Bismarck Cancer CenterBismarck, North Dakota  58501
U.S. Oncology Research Inc.Houston, Texas  77060
Comprehensive Cancer Care Specialists of Boca RatonBoca Raton, Florida  33428
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
Scripps Green Hospital & Scripps ClinicLa Jolla, California  92037
Citrus Memorial HospitalInverness, Florida  34452
St. Agnes HealthcareBaltimore, Maryland  21229
East Coast Radiation OncologyToms River, New Jersey  08755
Millard Fillmore HospitalBuffalo, New York  14209
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology GroupMemphis, Tennessee  38119
Memphis Regional Brain Tumor CenterMemphis, Tennessee  38104
Center for Radiation OncologyDanville, Virginia  24541