MDACC Study Summary 2004-0662

Study Summary
No. 2004-0662:.......Brain......Mark R. Gilbert......Neuro Oncology

Study Summary Title



Study Summary Number:	2004-0662

Study Title:	A RANDOMIZED, FACTORIAL-DESIGN, PHASE II TRIAL OF TEMOZOLOMIDE ALONE AND IN COMBINATION WITH POSSIBLE PERMUTATIONS OF THALIDOMIDE, ISOTRETINOIN AND/OR CELECOXIB AS POST-RADIATION ADJUVANT THERAPY OF GLIOBLASTOMA MULTIFORME

Physician

New Patient Referral



Name:	Mark R. Gilbert	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neuro Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8288 Contact us about clinical trials

General Information



Disease Group:	Brain	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Monthly

Treatment Agents:	Celecoxib Isotretinoin Temozolomide Thalidomide	Home Care:	N/A

Treatment Loc:	MDACC + Community Programs (CCOP/Network)

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if Temodar (temozolomide), when given alone or in combination with THALOMIDTM (thalidomide), Accutane (isotretinoin), and/or Celebrex (celecoxib), is effective in treating newly diagnosed glioblastoma multiforme in patients who have already been given radiation therapy. The safety of these treatments will also be studied.

Study Objectives / Outcomes

Primary
1. In patients with glioblastoma multiforme who have successfully completed radiotherapy, to determine the efficacy, measured in terms of progression-free survival 6 months after radiotherapy, of adjuvant treatment with temozolomide alone or in combination with the possible permutations of thalidomide, isotretinoin and/or celecoxib.
2. To determine the toxicity of temozolomide used in combination with thalidomide, isotretinoin and/or celecoxib in this manner in the adjuvant treatment of glioblastoma multiforme.
Secondary
1. To demonstrate the feasibility of conducting a randomized phase II trial with a factorial, multi-regimen design in a cooperative-group community cancer center setting.

Study Status Information



Study Activation / Registration Date:	09/21/2005

IRB Review and Approval Date:	11/17/2004

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	176

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with a diagnosis of supratentorial glioblastoma multiforme that has been proven by histology. Patients must have had either a biopsy, subtotal or gross total resection of their tumor.

2) Patients must have completed post-operative (or post-biopsy) radiotherapy. Concurrent temozolomide therapy during radiotherapy, as demonstrated to be superior to radiotherapy alone is not only allowed but recommended. No other concurrent chemotherapy is allowed.

3) Enrollment (registration) and randomization occurs after completion of, but no later than 5 weeks after, radiotherapy.

4) All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

5) Patients must be >/=18 years of age and have a Karnofsky performance status of >/= 60 (Karnofsky Performance Scale) at the time of enrollment.

6) Patients must have adequate bone marrow function (ANC >/=1,500/mm^3 and platelet count of >/= 100,000/mm^3), adequate liver function (SGPT and alkaline phosphatase <2 times ULN, bilirubin </=1.5 mg), and adequate renal function (BUN and creatinine </=1.5 times institutional normal) within 14 days prior to enrollment.

7) A baseline post-operative GD-DPTA MRI scan must be performed after radiotherapy and within 14 days prior to enrollment.

8) 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.

9) Patients must practice adequate birth control while on this study.

Exclusion Criteria:

1) Patients with active infection

2) Patients with a disease that will obscure toxicity or dangerously alter drug metabolism, for example; inflammatory bowel disease or severe connective tissue disease.

3) Patients with serious intercurrent medical illness.

4) Patients with a documented history of peptic ulcer disease or a history of active/recent GI bleeding (e.g., within the last 3 months).

5) Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to celecoxib or to sulfonamides and patients who have experienced asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs are excluded.

6) Patients who are pregnant or lactating.

Links

Registration Number: NCT00112502
Study Information on Clinical Trials Registry (clinicaltrials.gov)