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Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
carboplatin
pyrazoloacridine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed primary brain glioma Diffuse astrocytoma Gliosarcoma Oligodendroglioma Oligoastrocytoma Progressive disease after radiotherapy Measurable or evaluable disease by MRI or CT PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure requiring therapy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection No other active malignancy No other concurrent severe disease PRIOR CONCURRENT THERAPY: Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No more than 1 prior adjuvant chemotherapy regimen No prior polifeprosan 20 with carmustine implant (Gliadel wafer) Study 3 only: 1 prior chemotherapy regimen for recurrent disease allowed Prior nonplatinum-containing adjuvant chemotherapy allowed Prior platinum-containing adjuvant chemotherapy allowed if disease progressed at least 6 months after last treatment Endocrine therapy: Non-increasing dose of corticosteroids for at least 1 week allowed Radiotherapy: At least 12 weeks since prior radiotherapy No prior stereotactic radiosurgery or interstitial brachytherapy unless at least one lesion outside of irradiated area Surgery: No surgical resection since prior radiotherapy or chemotherapy unless evidence of disease progression or lesion outside of treatment site Other: Study 1 only: (Study 1 closed as of 03/29/02) Must be on anticonvulsants that can induce cytochrome P-450 (phenytoin, carbamazepine, barbiturates, or primidone) Study 2 only: (Study 2 closed as of 03/29/02) No concurrent anticonvulsants

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • Mayo Clinic
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Ochsner
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Health Plaza
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • Medcenter One Health System
  • CCOP - Merit Care Hospital
  • Altru Cancer Center
  • CCOP - Toledo Community Hospital
  • CCOP - Geisinger Clinic and Medical Center
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm Description

Patients receive carboplatin IV over 30 minutes and pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients receive the same treatment as given in study 1. Dose escalation is performed as in study 1 to determine the MTD in patients not receiving concurrent anticonvulsants.

Patients receive the same treatment as given in studies 1 and 2 without dose escalation.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
May 31, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005976
Brief Title
Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
Official Title
Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase I/II trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating patients who have recurrent glioma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of pyrazoloacridine plus carboplatin in patients with recurrent glioma. II. Determine the toxic effects of this treatment regimen in these patients. III. Determine the safety of this treatment regimen at the recommended phase II dose in patients not receiving anticonvulsants. IV. Determine the efficacy of this treatment regimen in these patients. V. Assess the pharmacokinetics and metabolism of pyrazoloacridine in these patients. VI. Assess the response rate, time to progression, and time to death in patients treated with this regimen. OUTLINE: This is a three-part, dose-escalation, multicenter study. Patients in study 3 are stratified according to concurrent anticonvulsants (yes vs no). STUDY 1: (Study 1 closed as of 03/29/02) Patients receive carboplatin IV over 30 minutes and pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. STUDY 2: (Study 2 closed as of 03/29/02) Patients receive the same treatment as given in study 1. Dose escalation is performed as in study 1 to determine the MTD in patients not receiving concurrent anticonvulsants. STUDY 3: Patients receive the same treatment as given in studies 1 and 2 without dose escalation. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: Study 1: A total of 3-21 patients will be accrued for this study within 6-20 months. Study 2: A total of 3-12 patients will be accrued for this study within 3-18 months. Study 3: A total of 12-37 patients will be accrued for this study within 15 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive carboplatin IV over 30 minutes and pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive the same treatment as given in study 1. Dose escalation is performed as in study 1 to determine the MTD in patients not receiving concurrent anticonvulsants.
Arm Title
Arm III
Arm Type
Experimental
Arm Description
Patients receive the same treatment as given in studies 1 and 2 without dose escalation.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
pyrazoloacridine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary brain glioma Diffuse astrocytoma Gliosarcoma Oligodendroglioma Oligoastrocytoma Progressive disease after radiotherapy Measurable or evaluable disease by MRI or CT PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure requiring therapy Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection No other active malignancy No other concurrent severe disease PRIOR CONCURRENT THERAPY: Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No more than 1 prior adjuvant chemotherapy regimen No prior polifeprosan 20 with carmustine implant (Gliadel wafer) Study 3 only: 1 prior chemotherapy regimen for recurrent disease allowed Prior nonplatinum-containing adjuvant chemotherapy allowed Prior platinum-containing adjuvant chemotherapy allowed if disease progressed at least 6 months after last treatment Endocrine therapy: Non-increasing dose of corticosteroids for at least 1 week allowed Radiotherapy: At least 12 weeks since prior radiotherapy No prior stereotactic radiosurgery or interstitial brachytherapy unless at least one lesion outside of irradiated area Surgery: No surgical resection since prior radiotherapy or chemotherapy unless evidence of disease progression or lesion outside of treatment site Other: Study 1 only: (Study 1 closed as of 03/29/02) Must be on anticonvulsants that can induce cytochrome P-450 (phenytoin, carbamazepine, barbiturates, or primidone) Study 2 only: (Study 2 closed as of 03/29/02) No concurrent anticonvulsants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evanthia Galanis, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Health Plaza
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501-5505
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Altru Cancer Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16133802
Citation
Galanis E, Buckner JC, Maurer MJ, Reid JM, Kuffel MJ, Ames MM, Scheithauer BW, Hammack JE, Pipoly G, Kuross SA. Phase I/II trial of pyrazoloacridine and carboplatin in patients with recurrent glioma: a North Central Cancer Treatment Group trial. Invest New Drugs. 2005 Oct;23(5):495-503. doi: 10.1007/s10637-005-2910-4.
Results Reference
result

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Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma

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