Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I/II Trial of Cloretazine® (VNP40101M) and Temodar® (Temozolomide) for Patients With Malignant Glioma in First Relapse or Progression
RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Temozolomide may also stop the growth of tumor cells by blocking blood flow to the
tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M when
given together with temozolomide and to see how well it works in treating patients with
progressive or relapsed malignant glioma.
OBJECTIVES:
- To determine the maximum tolerated dose (MTD) of VNP40101M when administered with
temozolomide in patients with progressive or relapsed (first relapse) malignant glioma.
(Phase I)
- To record the toxicities of VNP40101M when administered with temozolomide. (Phase I and
II)
- To measure the level of AGT expression in peripheral blood monocytes before treatment
with temozolomide and just prior to the administration of VNP40101M. (Phase I and II)
- To determine MGMT methylation status as well as other methylation patterns in blood and
tissue from patients treated with this regimen and correlate with outcome. (Phase I and
II)
- To determine the 6- and 12-month progression-free survival rates of patients treated
with this regimen. (Phase II)
- To determine overall survival of patients treated with this regimen. (Phase II)
- To determine the complete and partial response rates in patients treated with this
regimen. (Phase II)
- To determine CSF penetration of VNP40101M once the MTD is reached from phase I and
correlate with serum/plasma pharmacokinetics. (Phase II)
OUTLINE:
- Phase I: Patients receive oral temozolomide on days 1-7 and VNP40101M IV over 15-30
minutes 2 hours after the last dose of temozolomide on day 7. Treatment repeats every 7
weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated
dose (MTD) is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose limiting toxicity.
- Phase II: Patients receive oral temozolomide and VNP40101M as in phase I. VNP40101M is
given at the MTD determined in phase I.
In both phases, patients complete the Functional Assessment of Cancer Therapy-Brain
(FACT-BR) questionnaire on day 1 of each course.
Blood is collected for in vitro isolation of mononuclear cells for analysis of O^6
alkylguanine DNA alkyltransferase on days 1 and 7 of course 1. Blood, plasma, CSF, and
formalin-fixed paraffin-embedded tissue blocks are collected for gene methylation studies,
including MGMT, at baseline and on day 1 of each course.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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