Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Celgene Corporation
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
University of Virginia
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165477
First received: September 9, 2005
Last updated: March 8, 2010
Last verified: March 2010
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Purpose
- The purpose of this study is to find out if the combination of lenalidomide and radiation therapy is effective in controlling tumor growth in patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Gliosarcoma Malignant Gliomas |
Drug: lenalidomide Radiation: Radiation |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme. |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine the efficacy of lenalidomide with conventional radiation therapy in the treatment of patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the proportion of patients treated with lenalidomide and radiation therapy surviving at 12 months [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- to evaluate the time to tumor progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- the radiologic response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- to determine the safety and toxicity of the combination of lenalidomide and radiation therapy. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Enrollment: | 23 |
Study Start Date: | September 2005 |
Study Completion Date: | July 2009 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: lenalidomide
Given orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects
Other Name: Revlimid
Radiation: Radiation
Starting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks
Other Name: XRT
- Patients will receive lenalidomide orally once daily for 21 days followed by a one week rest period (this is equivalent to one cycle).
- Four to seven days from the first dose of lenalidomide, the patient will start radiation therapy for approximately 6-7 weeks.
- A neurologic exam and routine blood tests will be performed weekly while the patient is receiving radiation therapy.
- Following the 11th week of treatment a MRI/CT scan will be performed to assess the status of the tumor. If there is no change, or there is shrinkage in the size of the tumor, the treatment will continue for another 4 week cycle.
- The four week cycle will continue as long as the disease remains stable or improved and the patient does not develop intolerable side effects. A MRI/CT scan will be done every 2 cycles (8 weeks).
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histologically confirmed newly-diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma will be eligible for this protocol.
- The patient must have recovered from the effects of surgery, post-operative infections and other complications before entry into the study.
- Diagnosis will have been established by biopsy or resection no more than 28 days prior to registration.
- If tumor resection or open biopsy was performed, cranial MRI or contrast CT must have been performed before and after surgery. Imaging within 96 h of surgery is preferred but not required.
- If needle biopsy (stereotactic) was performed, gadolinium MRI or contrast CT within 14 days prior to registration is required. A post-operative scan is not required. The use of MRI rather than CT is preferred. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement. Patients without measurable or assessable disease are eligible.
- Patients receiving steroids must be on stable or decreasing doses for at least 5 days prior to entry.
- Patients must have a plan to begin partial brain radiotherapy 4-7 days after beginning lenalidomide, and within 35 days of the surgical procedure that established the diagnosis.
- Radiotherapy must be at the Radiation Oncology Department of the registered institution.
- Patients must be willing to forego cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with lenalidomide.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be > 18 years old, and with a life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of > 60.
- Patients must have adequate bone marrow, liver, and renal function.
- Patients must be willing and able to comply with all study requirements
Exclusion Criteria:
- Patient must not have had prior cranial radiation therapy.
- Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors. Patients who received Gliadel wafers will be excluded.
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy.
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- Patients must not have active infection.
- Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
- Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
- Patients must not have serious concurrent medical illness.
- Patient with recent thromboembolic disease (deep vein thrombosis and pulmonary embolism) are eligible if they are clinically stable and the thromboembolic event occurred more than 2 weeks prior to enrollment into this protocol.
- Patients must not have metastases below the tentorium or beyond the cranial vault.
- Patients must not have a known diagnosis of HIV, active infectious hepatitis, or chronic hepatitis.
- Patients must have no history of hypersensitivity or development of a desquamating rash while on thalidomide.
- Patients must have no prior exposure to lenalidomide.
- Previous or planned stereotactic radiosurgery or brachytherapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165477
Locations
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908-0394 |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Celgene Corporation
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
University of Virginia
Investigators
Principal Investigator: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
Keywords provided by Dana-Farber Cancer Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
Responsible Party: | Patrick Wen, MD, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00165477 History of Changes |
Other Study ID Numbers: | 05-222 |
Study First Received: | September 9, 2005 |
Last Updated: | March 8, 2010 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
Glioblastoma Gliosarcoma Malignant Gliomas |
Radiation Therapy IMiD Lenalidomide |
Additional relevant MeSH terms:
Glioblastoma Glioma Gliosarcoma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lenalidomide Thalidomide |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on October 16, 2012