Thema: Studie: ZD 1839 zur Behandlung von Glioblastomen
Studie: ZD 1839 zur Behandlung von Glioblastomen
Steffen[a]
14.12.2001 01:13:24
ZD 1839 in Treating Patients With Glioblastoma Multiforme
This study is currently recruiting patients.
Sponsored by
National Cancer Institute (NCI)
North Central Cancer Treatment Group
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme .
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme.
Condition Treatment or Intervention Phase
adult glioblastoma multiforme Drug: ZD 1839 Phase II
Study Type: Treatment
Official Title: Phase II Study of ZD 1839 in Patients With Glioblastoma Multiforme
Further Study Details:
OBJECTIVES: I. Determine treatment effectiveness in terms of response rate, time to progression, survival at 48 weeks, progression-free survival at 6 months, and overall survival in patients with glioblastoma multiforme treated with ZD 1839.
II. Determine the toxicity of this drug in these patients.
III. Assess fatigue, depression, excessive daytime somnolence, and quality of life in these patients treated with this drug.
IV. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients.
V. Determine if the type of epidermal growth factor receptor affects tumor response in patients treated with this drug.
PROTOCOL OUTLINE: This is a multicenter study.
Patients receive oral ZD 1839 daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
Patients are followed every 8 weeks until tumor progression.
Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study within 14 months.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Histologically confirmed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
Within 2-4 weeks of completion of standard external beam radiotherapy No evidence of tumor progression during radiotherapy
--Prior/Concurrent Therapy--
Biologic therapy: Not specified
Chemotherapy: No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor
Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics No prior stereotactic radiosurgery or interstitial brachytherapy
Surgery: No more than 13 weeks since prior surgery or biopsy
--Patient Characteristics--
Age: 18 and over
Performance status: ECOG 0-2
Life expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 3 times ULN
Renal: Creatinine no greater than 1.5 times ULN
Other: No other active malignancy No uncontrolled infection No other severe concurrent disease that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
Location and Contact Information
Arizona
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch 480-301-8296
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, Jr. 217-383-3010
Iowa
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld 319-363-8303
Iowa
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton 515-282-2921
Iowa
Siouxland Hematology-Oncology, Sioux City, Iowa, 51101-1733, United States; Recruiting
John C. Michalak 712-252-0088
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil 316-262-4467
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
James Edward Krook 218-786-8364
Minnesota
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Jan C. Buckner 507-284-4320
North Dakota
Medcenter One Health System, Bismarck, North Dakota, 58501, United States; Recruiting
Ferdinand E. Koranteng-Addo 701-250-7355
Ohio
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, 43623-3456, United States; Recruiting
Paul L. Schaefer 419-479-5605
Pennsylvania
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, Jr. 570-271-6413
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57105-1080, United States; Recruiting
Loren K. Tschetter 605-330-6510
South Dakota
Rapid City Regional Hospital, Rapid City, South Dakota, 57709, United States; Recruiting
Larry P. Ebbert 605-341-8901
Study chairs or principal investigators
Joon H. Uhm, Study Chair
North Central Cancer Treatment Group
More Information
More information is available for this study.
Study ID Numbers 199/15742; NCCTG-N0074
Date study started March 9, 2001
Last Updated June 1, 2001
NLM Identifier NCT00014170
ClinicalTrials.gov processed this record on 2001-12-13
This study is currently recruiting patients.
Sponsored by
National Cancer Institute (NCI)
North Central Cancer Treatment Group
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme .
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme.
Condition Treatment or Intervention Phase
adult glioblastoma multiforme Drug: ZD 1839 Phase II
Study Type: Treatment
Official Title: Phase II Study of ZD 1839 in Patients With Glioblastoma Multiforme
Further Study Details:
OBJECTIVES: I. Determine treatment effectiveness in terms of response rate, time to progression, survival at 48 weeks, progression-free survival at 6 months, and overall survival in patients with glioblastoma multiforme treated with ZD 1839.
II. Determine the toxicity of this drug in these patients.
III. Assess fatigue, depression, excessive daytime somnolence, and quality of life in these patients treated with this drug.
IV. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients.
V. Determine if the type of epidermal growth factor receptor affects tumor response in patients treated with this drug.
PROTOCOL OUTLINE: This is a multicenter study.
Patients receive oral ZD 1839 daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
Patients are followed every 8 weeks until tumor progression.
Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study within 14 months.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Histologically confirmed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma
Within 2-4 weeks of completion of standard external beam radiotherapy No evidence of tumor progression during radiotherapy
--Prior/Concurrent Therapy--
Biologic therapy: Not specified
Chemotherapy: No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor
Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics No prior stereotactic radiosurgery or interstitial brachytherapy
Surgery: No more than 13 weeks since prior surgery or biopsy
--Patient Characteristics--
Age: 18 and over
Performance status: ECOG 0-2
Life expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 3 times ULN
Renal: Creatinine no greater than 1.5 times ULN
Other: No other active malignancy No uncontrolled infection No other severe concurrent disease that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
Location and Contact Information
Arizona
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch 480-301-8296
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, Jr. 217-383-3010
Iowa
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld 319-363-8303
Iowa
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton 515-282-2921
Iowa
Siouxland Hematology-Oncology, Sioux City, Iowa, 51101-1733, United States; Recruiting
John C. Michalak 712-252-0088
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil 316-262-4467
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
James Edward Krook 218-786-8364
Minnesota
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Jan C. Buckner 507-284-4320
North Dakota
Medcenter One Health System, Bismarck, North Dakota, 58501, United States; Recruiting
Ferdinand E. Koranteng-Addo 701-250-7355
Ohio
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, 43623-3456, United States; Recruiting
Paul L. Schaefer 419-479-5605
Pennsylvania
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, Jr. 570-271-6413
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57105-1080, United States; Recruiting
Loren K. Tschetter 605-330-6510
South Dakota
Rapid City Regional Hospital, Rapid City, South Dakota, 57709, United States; Recruiting
Larry P. Ebbert 605-341-8901
Study chairs or principal investigators
Joon H. Uhm, Study Chair
North Central Cancer Treatment Group
More Information
More information is available for this study.
Study ID Numbers 199/15742; NCCTG-N0074
Date study started March 9, 2001
Last Updated June 1, 2001
NLM Identifier NCT00014170
ClinicalTrials.gov processed this record on 2001-12-13
Steffen[a]
