CNS Cancers

CURRENT CLINICAL TRIALS:


Phase 2 trial of Motexafin Gadolinium and Radiation and Temodar for patients with Glioblastoma sponsored by RTOG (Radiation Therapy Oncology Group)


Official Title

RTOG-0513: A Phase 1/2 Trial of Temozolomide, Motexafin Gadolinium, and 60 GY Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme


Purpose

This trial is studying the side-effects and best dose of motexafin gadolinium (MGd) when given together with temozolomide and radiation therapy and to evaluate the effects of the treatment regimen on overall and progression-free survival of patients with newly diagnosed supratentorial glioblastoma multiforme (GBM).


Study Design

This is a multicenter, dose-escalation study in 2 phases. In both phases, patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. They receive oral temozolomide once daily prior to radiotherapy on days 0-39, and they also receive intravenous MGd once daily prior to radiotherapy on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. In Phase 1, cohorts of 3-6 patients receive escalating doses of MGd until the maximum tolerated dose (MTD) is determined. Phase 2 patients undergo radiotherapy and receive temozolomide as in Phase 1; they also receive MGd as in Phase 1, at the MTD determined in Phase 1.

After completion of study treatment, patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Eligibility

To be included in the study, patients must meet the following general criteria:

  • At least 18 years of age
  • Newly diagnosed (by surgical biopsy or excision within the past 5 weeks), histologically confirmed GBM of supratentorial location
  • No prior systemic chemotherapy for the current GBM
  • No other concurrent chemotherapy
  • No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would result in overlap of radiation therapy fields
  • No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ≥ 3 years
  • No medical conditions that would increase risks of MGd treatment

For more details about this study, please refer to information posted at http://www.clinicaltrials.gov/ct/show/NCT00305864?order=3
or contact Radiation Therapy Oncology Group Protocol Co-Chair by email at lashby@chw.edu or at 602-406-6208; 800-227-7691


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Phase 2 trial of Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma


Official Title

A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood


Purpose

This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma.


Study Design

Patients will receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients will undergo focal cranial radiotherapy once daily 5 days a week for 6-7 weeks. Treatment will continue in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients will be followed every 3 months for 3 years and then periodically thereafter.


Eligibility
  • Up to 21 Years of age
  • Diagnosis of intrinsic pontine glioma (brain stem glioma)
    • Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically [> 50% intra-axial] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
    • Tumor may contiguously involve the thalamus or upper cervical cord
    • No more than 1 lesion/mass present at diagnosis
  • Karnofsky performance status (PS) 60-100% (age > 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
  • Life expectancy ≥ 8 weeks
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusion independent)
  • Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT < 1.5 times ULN
  • No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
    • If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
  • No biliary obstruction
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior definitive therapy for this specific tumor
  • No prior cranial radiotherapy
  • Concurrent steroids and anticonvulsants allowed
  • No concurrent proton therapy
  • No concurrent intensity-modulated radiotherapy
  • No concurrent anticancer chemotherapy
  • No concurrent immunomodulating agents

For more details about this study, please refer to information posted at http://clinicaltrials.gov/ct2/show/NCT00387790?term=pontine+motexafin&rank=1
Or contact Pharmacyclics Medical Affairs by email at MedicalAffairs@pcyc.com or 1.408.774.0330.


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