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Home > "T" Clinical Trials Conditions > Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme  Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
For Condition: Glioblastoma Multiforme
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: This study will combine the chemotherapy agent temozolomide with the investigational drug SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days.
Details: Temozolomide at a dose of, 150-200 mg/m2, will be administered orally, after fasting for one hour, once a day for 5 consecutive days (days 1 through 5) every 4 weeks. The starting dose level of 200 mg/m2 will be used for patients who have not previously received any chemotherapy or at 150 mg/m2 for patients who have received previous chemotherapy. SCH66336 will be given orally, with water, in the morning and in the evening for three weeks (Days 8 - 28) every 28 days 1 hour before or after morning and evening meals. Patients will take 150 mg in the morning and 150 mg in the evening. Treatment courses may be repeated every 28 days following the first daily dose of Temozolomide for the previous course.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - Patients with histologically proven supratentorial glioblastoma multiforme (GBM). - Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy. The scan done prior to study entry documenting progression will be reviewed by the primary investigator to document tumor volume changes to provide a gross assessment of growth rate. - Patients may have had: a) no prior chemotherapy, b) 1 prior adjuvant chemotherapy, c) 1 prior adjuvant chemotherapy followed by 1 regimen for recurrent disease, or d) 1 or 2 prior chemotherapy regimens for recurrent or progressive tumor. - All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital. - Patients who have not had a recent (< 4 weeks) complete resection must have measurable enhancing disease on MRI scan of the brain performed within 14 days of registration. Patients having undergone recent (< 4 weeks) complete resection and have no measurable disease on post operative MRI will also be eligible. - Patients must be > 18 years old, and with life expectancy > 8 weeks. - Patients must have a Karnofsky performance status of > 60 (Karnofsky Performance Scale; Appendix C). - 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, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair. - Patients must have adequate bone marrow function (ANC> 1,500/mm3 and platelet count of > 100,000/mm3), adequate liver function (SGPT and alkaline phosphatase <2 times normal, bilirubin <1.5 mg%), and adequate renal function (BUN and creatinine <1.5 times institutional normal) prior to starting therapy. - Patients must have a normal QT interval on an EKG done within 2 weeks prior to study entry. - Patients must not be taking primidone, carbamazepine, phenobarbital or phenytoin anticonvulsants. Patients changing from these anticonvulsants to others that are allowed must be off the drugs listed above for at least 72 hours. - 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: a) active infection b) disease that will obscure toxicity or dangerously alter drug metabolism c) serious intercurrent medical illness. d) prior recurrence with either Temozolomide or a farnesyl transferase inhibitor e) oral contraceptives and other hormonal methods (Depo-Provera) of birth control. - Patients must not be pregnant and both male and female patients must practice adequate contraception. Exclusion: - 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 with the following are ineligible: a) active infection b) pregnancy and must practice adequate contraception c) disease that will obscure toxicity or dangerously alter drug metabolism d) serious intercurrent medical illness e) previous treatment with either Temozolomide or a farnesyl transferase inhibitor f) oral contraceptives and other hormonal methods (Depo-Provera) of birth control.
Total Enrollment: 44
Location and Contact Information:
UTMD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Vivien Liu 713-792-2883
Additional Information:
Study ID Numbers: DM01-258;
Study Start Date: September 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038493
Other Glioblastoma Multiforme Studies:
1. Phase I Study of Tipifarnib with Radiation Therapy to Treat Glioblastoma Multiforme
2. Histologic Effect/Safety of Pre/Post-Operative IL13-PE38QQR in Recurrent Resectable Supratentorial Malignant Glioma Patients
3. Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
4. Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients with Recurrent Malignant Glioma
5. Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme
Related Studies:
Other Glioblastoma Multiforme Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
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