Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00085254
First received: June 10, 2004
Last updated: May 3, 2013
Last verified: April 2013
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Purpose
Cilengitide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving cilengitide together with temozolomide and radiation therapy may kill more tumor cells. This randomized phase I/II trial is studying the side effects and best dose of cilengitide when given together with temozolomide and radiation therapy and to compare how well they work in treating patients with newly diagnosed glioblastoma multiforme
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma |
Drug: cilengitide Drug: temozolomide Radiation: radiation therapy Other: laboratory biomarker analysis Other: pharmacological study |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Safety Run-in/Randomized Phase II Trial of EMD 121974 in Conjunction With Concomitant and Adjuvant Temozolomide With Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- MTD defined as the dose level producing dose limiting toxicity (DLT) in 2 out of 6 patients assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Overall failure rate (Phase II) [ Time Frame: From time of histological diagnosis to death occurrence, assessed up to 1 year ] [ Designated as safety issue: No ]The overall failure rate will be estimated by dividing the number of events (deaths) by the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.
Secondary Outcome Measures:
- Separate failure rates [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]The failure rates will be estimated by dividing the number of events (deaths) by the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated and reported as well. A comparison of the two survival curves of the treatment groups will be performed using non-parametric method of Log-Rank statistics.
- Frequency of grade 3 or 4 toxicities assessed using CTCAE version 4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals.
- Change in tumor blood volume, tumor blood flow, and permeability [ Time Frame: Baseline and up to 1 year ] [ Designated as safety issue: No ]Descriptive measures will be used to examine the difference and change overtime.
| Estimated Enrollment: | 112 |
| Study Start Date: | April 2005 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (lower dose cilengitide)
INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive radiotherapy and temozolomide as in phase I initiation course and cilengitide at a lower dose as in phase I initiation and maintenance courses. |
Drug: cilengitide
Given IV
Other Name: EMD 121974
Drug: temozolomide
Given orally
Other Names:
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
|
Experimental: Arm II (higher dose cilengitide)
INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6. MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive radiotherapy and temozolomide as in phase I initiation course and cilengitide at a higher dose as in phase I initiation and maintenance courses. |
Drug: cilengitide
Given IV
Other Name: EMD 121974
Drug: temozolomide
Given orally
Other Names:
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
- Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
- Absolute neutrophil count >= 1500/mm^3
- Platelets >= 100,000/mm^3
- Creatinine =< 1.5 mg/dl or creatinine clearance >= 60 mL/min
- Total bilirubin =< 1.5 mg/dl
- Transaminases =< 4 times above the upper limits of the institutional normal
- Patients must be able to provide written informed consent
- Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
- Patients must have a Mini Mental State Exam score of >= 15
- Patients must have tumor tissue form completed and signed by a pathologist
Exclusion Criteria:
- Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
- Patients who are pregnant or breast-feeding
- Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents)
- Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients who have been free of disease (any prior malignancy) for >= five years are eligible for this study
- Patients who are unable to undergo an MRI evaluation
- Patients with a history of wound-healing disorders, advanced coronary disease, or with a recent history (# 1 year) of peptic ulcer disease are ineligible
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085254
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Adult Brain Tumor Consortium | |
| Baltimore, Maryland, United States, 21231-1000 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-8936 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Massachusetts General Hospital | |
| Charlestown, Massachusetts, United States, 02129 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of The University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Louis Nabors | National Cancer Institute (NCI) |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00085254 History of Changes |
| Other Study ID Numbers: | NCI-2012-02932, NABTT 0306, CDR0000368451, U01CA062475 |
| Study First Received: | June 10, 2004 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013