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Sarasar and Temodar for Glioblastoma Multiforme Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00102648
Recruitment Status : Active, not recruiting
First Posted : February 1, 2005
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest safe dose of the new drug Sarasar (lonafarnib) that can be given together with Temodar (temozolomide) in a continuous daily dosing regimen to patients with brain tumors. The second goal is to learn if these drugs given in combination can shrink or slow the growth of brain tumors.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Gliosarcoma Brain Tumors Drug: Sarasar Drug: Temodar Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/Ib Study of Sarasar and Temodar in Patients With Recurrent or Temodar-Refractory Glioblastoma Multiforme
Actual Study Start Date : December 2004
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sarasar + Temodar

Sarasar Starting Dose: 100 mg by mouth twice a day, with water, for 7 consecutive days (Days 8-14 and Days 22-28). Cycle is 28 days.

Temodar 150 mg/m^2 by mouth once a day, after fasting one hour, for 7 consecutive days (Days 1-7 and Days 15-21). Cycle is 28 days.

Drug: Sarasar
Starting dose 100 mg by mouth twice a day, with water, for 7 consecutive days (days 8 through 14 and days 22 through 28). Cycle is 28 days.
Other Names:
  • Lonafarnib
  • SCH 66336
Drug: Temodar
150 mg/m^2 by mouth once a day, after fasting one hour, for 7 consecutive days (days 1 through 7 and days 15 through 21). Cycle is 28 days.
Other Name: Temozolomide

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) Sarasar when combined with Temodar in an alternating week schedule [ Time Frame: 28 Day Cycle ]
    MTD of Sarasar given with Temodar will be that dose at which fewer than one-third of participants experience dose limiting toxicity (DLT).

Secondary Outcome Measures :
  1. 6-month Progression-Free Survival [ Time Frame: 6 months ]
    Progression defined as 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Progression measured using combination of neurological examination and Magnetic Resonance Imaging (MRI) brain scan.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with histologically proven supratentorial glioblastoma multiforme (GBM) or gliosarcoma.
  2. 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 treating physician to document tumor volume changes to provide a gross assessment of growth rate.
  3. Patients may have had as many as 2 prior chemotherapy regimens for recurrent or progressive tumor. Patients must have had prior treatment with Temodar but may not have had prior treatment with farnesyl transferase inhibitors (Sarasar or Zarnestra). Patients in phase 1b expansion are required to have received a minimum of two cycles of adjuvant TMZ.
  4. 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.
  5. Patients must have shown unequivocal evidence for tumor progression by MRI or CT scan. A scan should be performed within 14 days prior to registration and on a steroid dose that has been stable or decreasing for at least 5 days. If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement.
  6. Pts having had recent resection of recurrent or progressive tumor are eligible as long as: a) Patients must be status post surgical resection at least 2 weeks prior to study enrollment, have recovered from surgery, have adequate early wound healing and a Karnofsky performance status of > or = 60.
  7. Continued from Inclusion #6. b) Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. A CT/ MRI should be done within 96 hrs post-op or at least 4 wks post-op (within 14 days of registration). If the steroid dose is increased between the scan date and registration, a new baseline MRI/CT is required on a stable steroid dose for 5 days.
  8. Patients must be >/= 18 years of age.
  9. Patients must have a Karnofsky performance status of >/= 60.
  10. 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.
  11. 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 <2.5 times normal, bilirubin <1.5 mg%), and adequate renal function (BUN and creatinine <1.5 times institutional normal) prior to starting therapy.

Exclusion Criteria:

  1. Patients must not be taking primidone, carbamazepine, phenobarbital or phenytoin anticonvulsants. Patients changing from these anticonvulsants to other allowable drugs that are not enzyme inducing antiepileptic drugs (EIAEDs) must be off the drugs listed above for at least 72 hours prior the initiation of treatment.
  2. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), are ineligible unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
  3. Patients must not have: a) uncontrolled active infection b) disease that will obscure toxicity or dangerously alter drug metabolism c) serious intercurrent medical illness. d) prior recurrence with a farnesyl transferase inhibitor e) oral contraceptives and other hormonal methods (Depo-Provera) of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102648

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: John DeGroot, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00102648     History of Changes
Other Study ID Numbers: 2004-0424
SPRI # P04084
NCI-2012-01311 ( Registry Identifier: NCI CTRP )
First Posted: February 1, 2005    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Glioblastoma Multiforme
Brain Tumors
SCH 66336

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors