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6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
This study is ongoing, but not recruiting participants.
First Received: July 18, 2007   Last Updated: June 29, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00504660
  Purpose

Primary Objectives:

  • To determine the efficacy, as measured by 12 month progression-free survival, of Temozolomide or CCNU with 6-Thioguanine followed by Capecitabine and Celecoxib in the treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma multiforme.
  • To determine the long-term toxicity of Temozolomide or CCNU with 6-Thioguanine followed by Capecitabine and Celecoxib in recurrent anaplastic glioma or glioblastoma multiforme patients treated in this manner.
  • To determine the clinical relevance of genetic subtyping tumors as a predictor of response to this chemotherapy and long term survival.

Condition Intervention Phase
Anaplastic Glioma
Glioblastoma Multiforme
Brain Cancer
Drug: Capecitabine
Drug: Celecoxib
Drug: Temozolomide
Drug: Lomustine
Drug: 6-Thioguanine
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2003
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Anaplastic Tumors: Active Comparator
Anaplastic Tumors - 6-TG, Temozolomide, Capecitabine and Celebrex
Drug: Capecitabine
Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
Drug: Celecoxib
Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
Drug: Temozolomide
Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
2: Anaplastic Tumors: Active Comparator
Anaplastic Tumors - 6-TG, Lomustine, Capecitabine and Celebrex
Drug: Capecitabine
Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
Drug: Celecoxib
Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
Drug: Lomustine
Arms 2,3 = 100 mg/m^2 PO on Day 4.
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
3: Glioblastoma Multiforme: Active Comparator
Glioblastoma Multiforme - 6-TG, Temozolomide, Capecitabine and Celebrex or 6-TG, Lomustine, Capecitabine and Celebrex
Drug: Capecitabine
Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
Drug: Celecoxib
Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
Drug: Temozolomide
Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
Drug: Lomustine
Arms 2,3 = 100 mg/m^2 PO on Day 4.
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients with histologically proven supratentorial anaplastic oligodendrogliomas, anaplastic mixed oligoastrocytomas anaplastic astrocytomas or glioblastoma multiforme.
  3. Patients must have unequivocal evidence for tumor recurrence or progression by MRI scan performed within 14 days prior to enrollment or documented recurrence by tumor resection. Patients must have received radiation therapy previously.
  4. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all the following conditions are met: a) Patients have recovered from the effects of surgery; b) Extent of residual disease (if present) has been documented by MRI performed no later than 72 hours after surgery or, if not possible, at least 4 weeks post-operative. Radiographic evidence of residual disease is not mandated for enrollment.
  5. The baseline on-study MRI is performed within 14 days of enrollment and on a steroid dosage that has been stable. If the steroid dose is increased between the date of imaging and the initiation of chemotherapy, a new baseline MRI is required on stable steroids for 7 days.
  6. Patients must be equal to or greater than 12 years old.
  7. Patients must have a Karnofsky performance status of equal to or greater than 60 (Karnofsky Performance Scale; Appendix D).
  8. 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.
  9. Patients must have adequate bone marrow function (ANC equal or greater than 1,500/mm3 and platelet count of equal or greater than 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.

Exclusion Criteria:

  1. 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 (1 year for localized prostate carcinoma treated by prostatectomy or irradiation) are ineligible.
  2. Patients of childbearing potential must not be pregnant or become pregnant.
  3. Patients must not have: a) active infection; b) disease that will obscure toxicity or dangerously alter drug metabolism; c) serious intercurrent medical illness; d) acute or chronic pulmonary disease, pulmonary embolus, hypertension, diabetes, metabolic syndrome, stroke, heart disease,myocardial infarction, angina, coronary angioplasty, congestive heart failure, or coronary bypass surgery; e) allergies to sulfa drugs; f) severe psychiatric illness; g) uncontrolled hypertension (i.e. ->135/>85 mm Hg) on three repeated measurements during the 6 weeks prior to enrollment on the study
  4. Patients must not have (continued): h) family history of premature coronary disease (i.e. - onset < 55 years of age); i) uncontrolled hypercholesteremia [low-density lipoprotein cholesterol (LDL-C >130]. Hypercholesteremia must be controlled for at least 3 months prior to enrollment on study; j) history of systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels; k) any indications for ASA deficiency
  5. Patients must not have had prior treatment with Capecitabine, 5-FU or a combination of Temozolomide with CCNU (Lomustine) or BCNU (Carmustine).

Patients who received only Temozolomide during radiation therapy and did not receive adjuvant chemotherapy with Temozolomide and/or those who received Gliadel (BCNU) wafers at surgery without adjuvant chemotherapy with BCNU or CCNU are eligible if 6 months has passed since the treatment(s).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504660

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Victor Levin, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Victor Levin, MD/Professor )
Study ID Numbers: 2003-0600
Study First Received: July 18, 2007
Last Updated: June 29, 2009
ClinicalTrials.gov Identifier: NCT00504660     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Anaplastic Glioma
Glioblastoma Multiforme
Brain Cancer
6-Thioguanine
Capecitabine
Celecoxib
Temozolomide
Xeloda
Temodar
TMZ
CCNU
6-TG

Study placed in the following topic categories:
Antimetabolites
Anti-Inflammatory Agents
Glioblastoma
Lomustine
Central Nervous System Neoplasms
Brain Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Glioblastoma Multiforme
Glioma
Alkylating Agents
Nervous System Neoplasms
Capecitabine
Celecoxib
Astrocytoma
Thioguanine
Cyclooxygenase Inhibitors
Central Nervous System Diseases
Temozolomide
Recurrence
Neuroectodermal Tumors
Brain Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Glioblastoma
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Brain Diseases
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Glioma
Alkylating Agents
Nervous System Neoplasms
Capecitabine
Neoplasms by Histologic Type
Celecoxib
Astrocytoma
Cyclooxygenase Inhibitors
Nervous System Diseases
Thioguanine
Central Nervous System Diseases
Enzyme Inhibitors
Temozolomide
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009