Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of PXD101 in Combination With 17-AAG in Advanced Malignancies
This phase I trial is studying the side effects and best dose of giving PDX101 together with 17-AAG in treating patients with metastatic or unresectable solid tumors or lymphoma. PDX101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving PXD101 together with 17-AAG may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of PXD101 and 17-AAG administered to patients
with refractory solid tumor malignancies.
II. To determine the maximum tolerated dose (MTD) and recommended phase II dose of PXD101
and 17-AAG in patients with refractory solid tumor malignancies.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of PXD101 and 17-AAG in patients receiving this
combination.
II. To evaluate the antitumor activity of this combination, per tumor measurements using the
RECIST criteria.
TERTIARY OBJECTIVES:
I. To evaluate the effect of treatment with PXD101 and 17-AAG on the transcriptional
upregulation of targeted genes in tumor and surrogate tissue (PBMCs) by means of RTPCR and
incorporation of the chromatin immunoprecipitation assay.
II. To evaluate the effect of this combination treatment on the post translational
modification of histones from tumor and surrogate tissue (PBMCs).
OUTLINE: This is a dose-escalation study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2 hours on days
1, 4, 8, and 11 and PXD101 IV over 30 minutes on days 1-5. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 17-AAG and PDX101 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. Up to 12 patients are treated at
the MTD.
Patients undergo blood collection on days 1 and 4 of course 1 for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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