Clinical trial · Interventional
Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma
NCT00005976CI-TRIAL-00010513completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| pyrazoloacridine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Drug: carboplatin
- Drug: pyrazoloacridine
- type
- EXPERIMENTAL
- label
- Arm II
- 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.
- interventionNames
- Drug: carboplatin
- Drug: pyrazoloacridine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGalanis 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