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Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma


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

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually for 5 years.


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.

Inclusion Criteria


- Histologically confirmed primary brain glioma

- Diffuse astrocytoma

- Gliosarcoma

- Oligodendroglioma

- Oligoastrocytoma

- Progressive disease after radiotherapy

- Measurable or evaluable disease by MRI or CT



- 18 and over

Performance status:

- ECOG 0-2


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

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL


- Bilirubin no greater than upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN


- Creatinine no greater than 2.0 mg/dL


- No myocardial infarction within the past 6 months

- No congestive heart failure requiring therapy


- 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



- 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


- At least 12 weeks since prior radiotherapy

- No prior stereotactic radiosurgery or interstitial brachytherapy unless at least one
lesion outside of irradiated area


- No surgical resection since prior radiotherapy or chemotherapy unless evidence of
disease progression or lesion outside of treatment site


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Evanthia Galanis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

May 2000

Completion Date:

April 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Mayo Clinic Jacksonville, Florida  32224
Medcenter One Health System Bismarck, North Dakota  58501
CentraCare Health Plaza Saint Cloud, Minnesota  56303
Altru Cancer Center Grand Forks, North Dakota  58206