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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


OBJECTIVES:

- Compare the efficacy of adjuvant temozolomide (TMZ) alone or in combination with
thalidomide and/or isotretinoin and/or celecoxib, in terms of 6-month progression-free
survival, in patients who have undergone radiotherapy for supratentorial glioblastoma
multiforme.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 8
treatment arms.

- Arm I: Patients receive oral temozolomide once daily on days 1-7 and 15-21.

- Arm II: Patients receive temozolomide as in arm I and oral thalidomide once daily on
days 1-28.

- Arm III: Patients receive temozolomide as in arm I and oral isotretinoin twice daily on
days 1-21.

- Arm IV: Patients receive temozolomide as in arm I and oral celecoxib twice daily on
days 1-28.

- Arm V: Patients receive temozolomide as in arm I, thalidomide as in arm II, and
isotretinoin as in arm III.

- Arm VI: Patients receive temozolomide as in arm I, thalidomide as in arm II, and
celecoxib as in arm IV.

- Arm VII: Patients receive temozolomide as in arm I, isotretinoin as in arm III, and
celecoxib as in arm IV.

- Arm VIII: Patients receive temozolomide as in arm I, thalidomide as in arm II,
isotretinoin as in arm III, and celecoxib as in arm IV.

In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity. Patient may receive additional courses of therapy at
the discretion of the treating physician.

After completion of study treatment, patients are followed for at least 30 days and then
every 3 months thereafter.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed supratentorial glioblastoma multiforme

- Must have undergone a biopsy OR subtotal or gross total resection of the tumor

- Must have completed post-operative (or post-biopsy) radiotherapy within the past 5
weeks

- No progressive disease after radiotherapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Serum glutamate pyruvate transaminase (SGPT) < 2 times upper limit of normal (ULN)

- Alkaline phosphatase < 2 times ULN

- Bilirubin ≤ 1.5 mg/dL

Renal

- blood urea nitrogen (BUN) ≤ 1.5 times ULN

- Creatinine ≤ 1.5 times ULN

Immunologic

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to celecoxib or to sulfonamides

- No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs

- No active infection

Gastrointestinal

- No inflammatory bowel disease

- No history of peptic ulcer disease

- No gastrointestinal bleeding within past 3 months

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception during and for 2
months after study participation

- Fertile female patients randomized to receive thalidomide must use effective
double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after
completion of study therapy

- Fertile male patients randomized to receive thalidomide must use effective
contraception during and for ≥ 4 weeks after completion of study therapy

- No blood donation (for patients randomized to receive thalidomide)

- No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of
the cervix or cancer that is in complete remission and patient completed all therapy
for that disease ≥ 3 years ago

- No other disease that would obscure toxicity or dangerously alter drug metabolism
(e.g., severe connective tissue disease)

- No other serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Prior temozolomide in combination with radiotherapy allowed

- No other prior or concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- See Chemotherapy

Surgery

- See Disease Characteristics

- No concurrent surgery

Other

- No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients
randomized to receive celecoxib)

- No other concurrent investigational drugs

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Outcome Description:

Number of participants with no disease progression, measured at 6 months. A combination of the neurological examination and MRI brain scan used to define progression.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Mark R. Gilbert, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

2004-0662

NCT ID:

NCT00112502

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Central IllinoisSpringfield, Illinois  62526
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Grand RapidsGrand Rapids, Michigan  49503
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, Arkansas  72903
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240