Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
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| ClinicalTrials.gov Identifier: NCT00005976 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 3, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors | Drug: carboplatin Drug: pyrazoloacridine | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma |
| Study Start Date : | May 2000 |
| Actual Primary Completion Date : | December 2006 |
| Actual Study Completion Date : | April 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
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 |
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Experimental: Arm II
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.
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Drug: carboplatin Drug: pyrazoloacridine |
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Experimental: Arm III
Patients receive the same treatment as given in studies 1 and 2 without dose escalation.
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Drug: carboplatin Drug: pyrazoloacridine |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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)
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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:
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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)
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Study 2 only: (Study 2 closed as of 03/29/02)
- No concurrent anticonvulsants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005976
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| Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005976 |
| Other Study ID Numbers: |
NCI-2012-01850 NCCTG-987254 CDR0000067963 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 3, 2013 |
| Last Verified: | September 2003 |
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recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
adult mixed glioma adult oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
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Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Carboplatin NSC 366140 Antineoplastic Agents |