Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00050986

Purpose

The goal of this clinical research study is to find the highest safe dose of the new drug ZARNESTRA (R115777) and temozolomide that can be given to patients with brain tumors (glioblastoma multiforme, GBM). The second goal is to learn if these drugs given in combination can shrink or slow the growth of brain tumors. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: temozolomide and R115777	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Evaluation Temozolomide and Farnesyl Transferase Inhibitor ZARNESTRA (R115777) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

Drug Information available for: Temozolomide R 115777 Tipifarnib

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	74
Study Start Date:	December 2002

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with supratentorial glioblastoma multiforme (GBM).
Patients must have tumor recurrence or progression by MRI scan after radiation therapy.
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
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 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.
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
1. They have recovered from the effects of surgery.
2. Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration. If the 96-hour scan is more than 14 days before registration, the scan needs to be repeated. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days.
Patients must have a Karnofsky performance status of > 60
Patients must have recovered from the toxic effects of prior therapy.
Patients must have adequate bone marrow function, adequate liver function and adequate renal function prior to starting therapy.
ZARNESTRA may interfere with coumadin dosing and patients who are taking this combination will require more frequent monitoring of their PT, PTT and INR.
Patients must not be taking primidone, carbamazepine, phenobarbital or phenytoin anticonvulsants.
Patients must not be taking cimetidine, erythromycin azole antifungals, paclitaxel, tacrolimus or cyclosporine.
Patients must not have uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia..
Because of the concerns of potentially harmful interactions of ZARNESTRA and other medications taken by patients who are HIV positive or have AIDS related diseases, patients who are HIV positive will not be eligible for entry into this study. Only patients with suspected HIV will be tested and if positive, will be ineligible.
Patients must not have 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:
1. active infection
2. disease that will obscure toxicity or dangerously alter drug metabolism
3. serious intercurrent medical illness.
4. prior recurrence with either Temozolomide or a farnesyl transferase inhibitor
Patients must not be pregnant and must practice adequate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050986

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Mark R. Gilbert

MDAnderson Cancer Center

More Information

No publications provided

Study ID Numbers:	ID02-126
Study First Received:	December 31, 2002
Last Updated:	February 10, 2006
ClinicalTrials.gov Identifier:	NCT00050986 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Brain Neoplasms
CNS Diseases

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Central Nervous System Diseases
Temozolomide
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Antineoplastic Agents, Alkylating
Glioma
Glioblastoma Multiforme
Alkylating Agents
Neoplasms, Glandular and Epithelial
Tipifarnib

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial
Tipifarnib

ClinicalTrials.gov processed this record on July 02, 2009