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Phase I/II Study of EMD 121974 in Patients With Progressive or Recurrent Malignant Glioma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II, Phase I
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Treatment
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Completed
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18 and over
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NCI
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NABTT-9911 JHOC-NABTT-9911, NCT00006093, NABTT-9911
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Objectives - Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in patients with progressive or recurrent malignant glioma.
- Determine the 6-month progression-free survival, clinical response rate, duration of progression-free survival, and overall survival in patients treated with this drug.
- Determine the effects of this drug on tumor perfusion, measured with magnetic resonance perfusion scan, and markers for angiogenesis in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy
- Eligible subtypes:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Prior low-grade glioma that has progressed to a
high-grade glioma (by biopsy)
after radiotherapy and/or chemotherapy allowed
- Measurable disease by volumetric and magnetic resonance perfusion scan
- Prior biopsy or resection of recurrent brain tumor allowed
Prior/Concurrent Therapy:
Biologic therapy: - No concurrent filgrastim (G-CSF)
Chemotherapy: - See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for
nitrosoureas) and recovered
- No more than 2 prior chemotherapy regimens
Endocrine therapy: - Prior corticosteroids allowed if on stable dose for at least 5
days prior to study
- Concurrent corticosteroids (e.g., dexamethasone) allowed as
clinically needed
Radiotherapy: - See Disease Characteristics
- At least 3 months since prior radiotherapy and
recovered
Surgery: - See Disease Characteristics
- At least 1 week since prior surgery and recovered
- No concurrent elective surgery or dental extractions
Other: - No other concurrent investigational agents
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic: - Bilirubin normal
- Transaminases no greater than 2.5 times upper limit of
normal
Renal: - Creatinine no greater than 1.5 mg/dL
OR - Creatinine clearance at least 60 mL/min
Cardiovascular: - No advanced coronary artery disease
Other: - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious concurrent infection or medical illness that would
preclude study
- No other malignancy within the past 5 years except curatively
treated carcinoma in situ or basal cell skin cancer
- No history of wound healing disorders
- No peptic ulcer disease within the past year
- Mini mental score of at least 15
- Willing and able to undergo MRI
Expected Enrollment A minimum of 6 patients will be accrued for phase I of this study within 2-3 months. A total of 23-38 patients will be accrued for phase
II of this study within 5-10 months. Outline This is a dose-escalation, multicenter study. Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat
every 4 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 6-12 patients receive escalating doses of EMD 121974 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which more than 2 of 6 or 4 of 12 patients experience
dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD. Patients are followed every 2 months. Published ResultsNabors LB, Mikkelsen T, Rosenfeld SS, et al.: Phase I and correlative biology study of cilengitide in patients with recurrent malignant glioma. J Clin Oncol 25 (13): 1651-7, 2007.[PUBMED Abstract] Nabors LB, Rosenfeld SS, Mikkelsen T, et al.: NABTT 9911: a phase I trial of EMD 121974 for treatment of patients with recurrent malignant gliomas. [Abstract] Neuro-Oncology 6 (4): TA-39, 379, 2004.
Trial Contact Information
Trial Lead Organizations New Approaches to Brain Tumor Therapy | | | Louis Nabors, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Phase I/II Trial of EMD 121974 for Treatment of Patients with Recurrent Anaplastic Gliomas | | Trial Start Date | | 2000-09-21 | | Registered in ClinicalTrials.gov | | NCT00006093 | | Date Submitted to PDQ | | 2000-06-26 | | Information Last Verified | | 2003-04-01 | | NCI Grant/Contract Number | | CA006973, CA062475 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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