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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00412542 |
Purpose
1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.
1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.
1.3 To determine TTP, overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.
1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme Glioma |
Drug: Thalidomide Drug: CPT-11 Procedure: MRI Scan Procedure: Quantitative Sensory Tests (QST) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme |
| Estimated Enrollment: | 78 |
| Study Start Date: | October 2003 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Thalidomide + CPT-11
|
Drug: Thalidomide
100 mg PO (by mouth) daily x 8 weeks
Drug: CPT-11
125 mg/m^2 by vein weekly over 90 minutes x 4 weeks, followed by 2 weeks rest
Procedure: MRI Scan
Dynamic MRI scan with dye injection through vein, every 6 weeks
Procedure: Quantitative Sensory Tests (QST)
QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.
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Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.
Before treatment, you will have a complete physical exam. Your height and weight will be measured. You will have blood drawn for routine blood tests (less than 2 tablespoons). You will have a MRI. For this MRI, you will have a special dye injected into a vein to highlight the tumor on the MRI scan. You will also have a special MRI test done called a dynamic MRI scan. For this MRI, another dose of the same dye will be injected into a vein. The MRI machine will then take pictures to find out how fast the dye moves into the tumor. Women who are able have children must have a negative blood pregnancy test.
You will also have quantitative sensory tests (QST) to check for any nerve problems that may be present before starting treatment. In this test, you will touch a small machine to test your feeling of touch, vibration, and temperature. If the doctor feels it is necessary you may also have an EMG/NCS (electromyography/nerve conduction study). In this test, a small electrical shock is delivered to surface of the skin to check for any nerve problems. A small needle may also be placed in the skin to check on muscle activity.
All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects.
In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years.
During treatment you will have blood drawn (less than 1 tablespoon) for routine tests every 2 weeks. You will come to the outpatient clinic at the end of each course of treatment for a complete physical and neurological exams. At these visits, you will also have a MRI scan with dynamic study, blood tests (less than 2 tablespoons), and a pregnancy test (for women who are able to have children). Repeat QST testing will be done after every 2 courses of therapy. If your doctor feels it is necessary, you may have repeat NCS tests at any time if you develop nerve problems.
If at any time during treatment the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. You may not receive any other investigational drug or have any other treatment for the cancer, including surgery, while taking part in this study.
THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational.
Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Is there an age limit? No
Inclusion Criteria:
Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, cis-retinoic acid, etc.
(radiosensitizer does not count). Patients who receive either Temozolomide or CPT-11 for non-therapeutic purposes (such as presurgically for obtaining pharmacology data for the agent) will be eligible for study entry provided they have recovered from the toxic effects of the agent if any.
Exclusion Criteria:
Patients must not have: a) active infection b) disease that will obscure toxicity or dangerously alter drug metabolism c) serious intercurrent medical illness. d) prior recurrence with CPT-11 (for the CPT-11 + Thalidomide arm) (prior treatment with thalidomide is permitted). e) grade 2 or higher peripheral neuropathy.
Patients who have received Temozolomide or CPT-11 for non-therapeutic purposes (for eg., as part of a pharmacology study without therapeutic intent) will remain eligible for enrollment into the study.
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Vinay K. Puduvalli, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Vinay K. Puduvalli, MD/Associate Professor ) |
| Study ID Numbers: | DM02-595 |
| Study First Received: | December 15, 2006 |
| Last Updated: | February 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00412542 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Glioblastoma Multiforme Glioma Thalidomide Thalomid |
CPT-11 Irinotecan malignant glioma |
|
Anti-Infective Agents Glioblastoma Immunologic Factors Astrocytoma Thalidomide Irinotecan Angiogenesis Inhibitors Immunosuppressive Agents Temozolomide Recurrence |
Camptothecin Anti-Bacterial Agents Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
|
Glioblastoma Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Irinotecan Neoplasms, Nerve Tissue Physiological Effects of Drugs Anti-Bacterial Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Angiogenesis Modulating Agents |
Growth Inhibitors Neoplasms by Histologic Type Astrocytoma Growth Substances Enzyme Inhibitors Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial Leprostatic Agents |
