Status:
COMPLETED
ATN-161 and Carboplatin in Treating Patients With Recurrent Malignant Glioma
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, ei...
Detailed Description
OBJECTIVES: Primary * Establish the safety of ATN-161 and carboplatin in patients with recurrent intracranial malignant glioma. * Determine the maximum tolerated dose of ATN-161 when administered wi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed intracranial malignant glioma
- Original low-grade glioma histology allowed provided there is subsequent histologic confirmation of malignant glioma
- Any of the following diagnoses:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant astrocytoma not otherwise specified
- Recurrent disease
- Must have failed prior radiotherapy
- Must have confirmation of true progressive disease (rather than radiation necrosis) based upon either positron emission tomography or thallium scanning, MR spectroscopy, or surgical documentation of disease if radiographic recurrence is within the high-dose radiation field (for patients who underwent prior interstitial brachytherapy or stereotactic radiosurgery)
- Prior recent resection of recurrent or progressive tumors allowed if all of the following criteria are met:
- Recovered from prior surgery
- Evaluable disease after resection
- Unequivocal evidence of tumor progression by MRI
- Steroid dose must be stable for ≥ 5 days prior to MRI
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy \> 8 weeks
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- AST \< 2.5 times upper limit of normal (ULN)
- Bilirubin \< 2.5 times ULN
- Creatinine \< 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after completion of study treatment
- No significant medical illness that would preclude study treatment
- No history of other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless disease is in complete remission and off all therapy for ≥ 1 year
- No active infection or serious intercurrent medical illness
- No disease that will obscure toxicity or dangerously alter drug metabolism
- Able to undergo MRI scan and receive contrast agents for perfusion scanning
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 28 days since prior cytotoxic therapy
- At least 14 days since prior vincristine
- At least 42 days since prior nitrosoureas
- At least 21 days since prior procarbazine
- At least 7 days since prior interferon, tamoxifen, thalidomide, isotretinoin, or other noncytotoxic agents (radiosensitizer does not count)
- At least 14 days since prior noncytotoxic investigational agents
- At least 42 days since prior radiotherapy
- No prior cisplatin, carboplatin, oxaliplatin, or platinum-containing analogue
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- No other concurrent anticancer therapy (including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy)
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00352313
Start Date
May 1 2006
End Date
January 1 2008
Last Update
May 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182