Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma

NCT00005976 | Completed Phase 2

• 3 other identifiers: NCI-2012-01850NCCTG-987254CDR0000067963
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 23

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.

Conditions

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

Study Arms (3)

Arm I

EXPERIMENTAL

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.

Drug: carboplatin; Drug: pyrazoloacridine

Arm II

EXPERIMENTAL

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.

Drug: carboplatin; Drug: pyrazoloacridine

Arm III

EXPERIMENTAL

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

Drug: carboplatin; Drug: pyrazoloacridine

Interventions

carboplatin DRUG

Arm I; Arm II; Arm III

pyrazoloacridine DRUG

Arm I; Arm II; Arm III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (23)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• 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.

  PMID: 16133802 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Gliosarcoma

Interventions

Carboplatin; NSC 366140

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Evanthia Galanis, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: May 1, 2000
• Primary Completion: December 1, 2006
• Study Completion: April 1, 2007
• Last Updated: June 3, 2013

Record last verified: 2003-09

Locations

CA (1); US (22)