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Last Modified: 11/3/2009     First Published: 5/11/2006  
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Phase I/II Study of Sorafenib and Temsirolimus in Patients With Recurrent Glioblastoma (Phase I Closed to Accrual as of 11/21/07)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Sorafenib and Temsirolimus in Treating Patients With Recurrent Glioblastoma

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCCTG-N0572
N0572, NCT00329719

Objectives

Primary

  1. Establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants (EIACs). (Phase I [closed to accrual as of 11/21/07])
  2. Define the safety profile of temsirolimus and sorafenib in these patients. (Phase I [closed to accrual as of 11/21/07])
  3. Assess the evidence of antitumor activity. (Phase I [closed to accrual as of 11/21/07])
  4. Assess the efficacy, as measured by progression-free survival, of temsirolimus and sorafenib in patients with recurrent glioblastoma not receiving EIACs . (Phase II)
  5. Assess the safety and toxicities of this regimen in these patients. (Phase II)

Secondary

  1. Correlate tumor and blood biomarkers with clinical outcome of patients treated with temsirolimus and sorafenib.
  2. Evaluate tumor tissue specimens for evidence of bioactivity of these agents.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed grade IV astrocytoma (glioblastoma) or gliosarcoma

  • Evidence of tumor progression by MRI or CT scan after prior radiotherapy or most recent antitumor therapy

  • Bidimensionally measurable or evaluable disease by MRI or CT scan

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • At least 12 weeks since prior radiotherapy
  • At least 6 weeks since prior temsirolimus, sorafenib, or other agents specifically targeting mTOR, raf, or vascular endothelial growth factor (VEGF)/VEGF receptors and recovered
    • No prior poor tolerance to such agents
  • At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
  • At least 2 weeks since prior cytostatic chemotherapy (e.g., tamoxifen, isotretinoin, or thalidomide)
  • At least 1 week since prior fixed or decreasing dose of corticosteroids (or no corticosteroids)
  • At least 1 week since prior minor surgery other than venous line placement (3 weeks for major surgery)
  • No more than 2 prior systemic chemotherapy regimens
  • No prior surgical procedures affecting absorption
  • No prior intratumoral chemotherapy (e.g., polifeprosan 20 with carmustine implant or cintredekin besudotox), stereotactic radiosurgery, or interstitial brachytherapy unless there is a separate lesion on MRI that is not part of the previous treatment field or there is proof of recurrent disease based on biopsy, MRI spectroscopy, or positron emission tomography scan
  • No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone) or any other potent CYP3A4 inducer, such as rifampin or Hypericum perforatum (St. John’s wort)
  • No other concurrent investigational agents
  • No concurrent prophylactic hematopoietic colony-stimulating factors
  • No other concurrent anticancer agents or therapies
  • Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided coagulation parameter levels (prothrombin time [INR]) < 1.1 times upper limit of normal (ULN)
  • Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided all of the following criteria are met:
    • In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
    • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)

Patient Characteristics:

  • ECOG performance status 0-2
  • WBC ≥ 3,000/mm3
  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 2.0 times ULN
  • AST ≤ 2.5 times ULN
  • Creatinine ≤ 2.0 times ULN
  • Cholesterol ≤ 350 mg/dL
  • Triglycerides ≤ 400 mg/dL
  • INR ≤ 1.5 (unless on full-dose warfarin)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after completion of study therapy
  • No HIV positivity
  • No evidence of bleeding diathesis or coagulopathy
  • No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, or active peptic ulcer disease) that would impair the ability to swallow pills
  • No uncontrolled hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP pressure > 90 mm Hg
  • No uncontrolled infection
  • No known hypersensitivity to any of the components of temsirolimus or sorafenib
  • No immunocompromised patients (other than that related to the use of corticosteroids)
  • No other active malignancy
  • No uncontrolled intercurrent illness, including, but not limited to, any of the following:
    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would preclude study compliance
  • No significant intratumoral, intracerebral, or subarachnoid hemorrhage on baseline MRI or CT scan
  • No other history of significant intratumoral, intracerebral, or subarachnoid hemorrhage

Expected Enrollment

141

A total of 141 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Progression-free survival at 6 months

Secondary Outcome(s)

Time to disease progression
Overall survival
Objective response
Adverse events as assessed by NCI CTCAE v3.0
Correlation of biomarkers with antitumor activity/patient outcomes

Outline

This is a multicenter, phase I (closed to accrual as of 11/21/07), dose-escalation study of temsirolimus followed by a phase II open-label study.

  • Phase I (closed to accrual as of 11/21/07): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

    Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients are assigned to 1 of 2 treatment groups.
    • Group 1 (patients not undergoing surgery): Patients receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD.

    • Group 2 (patients undergoing surgery): Patients receive oral sorafenib twice daily on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD.

    • Group 3 (patients who have received prior anti-VEGF therapy and are not undergoing surgery): Patient receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD.

Biopsy or resected tissue and blood are collected prior to treatment (usually at diagnosis) and analyzed for biomarkers.

After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Kurt Jaeckle, MD, Protocol chair
Ph: 904-953-7102
David Schiff, MD, Protocol co-chair
Ph: 434-982-4415; 800-223-9173
Bradley Erickson, MD, PhD, Protocol co-chair
Ph: 507-284-2511
Email: erickson.bradley@mayo.edu

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Florida
  Jacksonville
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Illinois
  Bloomington
 St. Joseph Medical Center
 John Kugler, MD
Ph: 309-243-3605
  Canton
 Graham Hospital
 John Kugler, MD
Ph: 309-243-3605
  Carthage
 Memorial Hospital
 John Kugler, MD
Ph: 309-243-3605
  Eureka
 Eureka Community Hospital
 John Kugler, MD
Ph: 309-243-3605
  Galesburg
 Galesburg Clinic, PC
 John Kugler, MD
Ph: 309-243-3605
 Galesburg Cottage Hospital
 John Kugler, MD
Ph: 309-243-3605
  Havana
 Mason District Hospital
 John Kugler, MD
Ph: 309-243-3605
  Macomb
 McDonough District Hospital
 John Kugler, MD
Ph: 309-243-3605
  Normal
 BroMenn Regional Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Community Cancer Center
 John Kugler, MD
Ph: 309-243-3605
  Ottawa
 Community Hospital of Ottawa
 John Kugler, MD
Ph: 309-243-3605
 Oncology Hematology Associates of Central Illinois, PC - Ottawa
 John Kugler, MD
Ph: 309-243-3605
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peoria
 CCOP - Illinois Oncology Research Association
 John Kugler, MD
Ph: 309-243-3605
 Methodist Medical Center of Illinois
 Clinical Trials Office - Methodist Medical Center of Illinois
Ph: 309-243-3000
 Oncology Hematology Associates of Central Illinois, PC - Peoria
 John Kugler, MD
Ph: 309-243-3605
 OSF St. Francis Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Proctor Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peru
 Illinois Valley Community Hospital
 John Kugler, MD
Ph: 309-243-3605
  Spring Valley
 St. Margaret's Hospital
 John Kugler, MD
Ph: 309-243-3605
Iowa
  Ames
 McFarland Clinic, PC
 Clinical Trials Office - McFarland Clinic, PC
Ph: 515-239-2621
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Clinical Trials Office - Cedar Rapids Oncology Associates
Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Martin Wiesenfeld, MD
Ph: 319-363-8303
  Clive
 Medical Oncology and Hematology Associates - West Des Moines
 Robert Behrens
Ph: 515-875-9713
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert Behrens
Ph: 515-244-7586
888-244-6061
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital
Ph: 515-241-8704
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert Behrens
Ph: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert Behrens
Ph: 515-643-8740
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert Behrens
Ph: 515-643-8206
888-221-4849
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa
Ph: 641-422-6304
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Wender, MD, PhD
Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Wender, MD, PhD
Ph: 712-252-0088
Kansas
  Anthony
 Hospital District Sixth of Harper County
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Southwest Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip Stella, MD
Ph: 734-712-1000
 Saint Joseph Mercy Cancer Center
 Philip Stella, MD
Ph: 734-712-1000
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Iron Mountain
 Dickinson County Healthcare System
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Lansing
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Pontiac
 St. Joseph Mercy Oakland
 Philip Stella, MD
Ph: 734-712-1000
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
Minnesota
  Alexandria
 Donald Jurgens
Ph: 320-229-4907
  Bemidji
 MeritCare Bemidji
 Preston Steen, MD
Ph: 701-234-2397
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Duluth
 CCOP - Duluth
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
 Duluth Clinic Cancer Center - Duluth
 Clinical Trials Office - Duluth Clinic Cancer Center - Duluth
Ph: 218-786-3308
 Miller - Dwan Medical Center
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Hutchinson
 Hutchinson Area Health Care
 Daniel Anderson
Ph: 320-234-5000
800-454-3903
  Lichfield
 Meeker County Memorial Hospital
 Clinical Trials Office - Meeker County Memorial Hospital
Ph: 320-693-4520
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel Anderson
Ph: 651-232-7970
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - River Campus
 Donald Jurgens
Ph: 320-229-4907
 Coborn Cancer Center
 Donald Jurgens
Ph: 320-229-4907
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Joseph Ryan, MD
Ph: 320-231-6359
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Nebraska
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center
Ph: 402-398-6060
 CCOP - Missouri Valley Cancer Consortium
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 Creighton University Medical Center
 Clinical Trials Office - Creighton University Medical Center
Ph: 402-280-4100
 Immanuel Medical Center
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
North Carolina
  Rutherfordton
 Rutherford Hospital
 James Bearden, MD
Ph: 864-560-6812
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward Wos, DO
Ph: 701-323-5741
 Medcenter One Hospital Cancer Care Center
 Edward Wos, DO
Ph: 701-323-5741
 Mid Dakota Clinic, PC
 Clinical Trials Office - Mid Dakota Clinic, PC
Ph: 701-530-6950
 St. Alexius Medical Center Cancer Center
 Clinical Trials Office - St. Alexius Medical Center Cancer Center
Ph: 701-530-6950
  Fargo
 CCOP - MeritCare Hospital
 Preston Steen, MD
Ph: 701-234-2397
 MeritCare Broadway
 Preston Steen, MD
Ph: 701-234-2397
  Grand Forks
 Altru Cancer Center at Altru Hospital
 Clinical Trails Office - Altru Cancer Center at Altru Hospital
Ph: 701-780-6520
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Suresh Nair, MD
Ph: 610-402-0512
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  Hazleton
 Geisinger Hazleton Cancer Center
 Amy Law, MD
Ph: 570-271-6045
  State College
 Geisinger Medical Group - Scenery Park
 Amy Law, MD
Ph: 570-271-6045
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Ph: 570-271-5251
South Carolina
  Anderson
 AnMed Cancer Center
 Clinical Trials Office - AnMed Cancer Center
Ph: 864-512-1000
  Spartanburg
 CCOP - Upstate Carolina
 Clinical Trials Office - CCOP - Upstate Carolina
Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Clinical Trials Office - Gibbs Regional Cancer Center
Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Richard Tenglin
Ph: 605-719-2360
Virginia
  Charlottesville
 University of Virginia Cancer Center
 David Schiff, MD
Ph: 434-982-4415
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
 St. Mary's Hospital Medical Center - Green Bay
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
 St. Vincent Hospital Regional Cancer Center
 Clinical Trials Office - St. Vincent Hospital Regional Cancer Center
Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135

Registry Information
Official Title A Phase I/II Trial of Sorafenib and CCI-779 in Combination with Recurrent Glioblastoma
Trial Start Date 2006-03-24
Trial Completion Date 2010-03-03 (estimated)
Registered in ClinicalTrials.gov NCT00329719
Date Submitted to PDQ 2006-03-23
Information Last Verified 2009-11-03
NCI Grant/Contract Number CA25224

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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