Leukemia Clinical Trial
Official title:
A Phase I Study of Cordycepin (NSC 63984) Plus 2'-Deoxycoformycin (NSC 218321) in Patients With Refractory TdT-Positive Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin
plus pentostatin in treating patients with refractory acute lymphocytic or chronic
myelogenous leukemia.
OBJECTIVES: I. Evaluate the safety, maximum tolerated dose, adverse effects, and toxicities
of cordycepin, given 1 hour following a fixed dose of the adenosine deaminase inhibitor
pentostatin, in patients with refractory TdT positive leukemia. II. Determine the single and
multiple dose pharmacokinetics of cordycepin given 1 hour following a fixed dose of
pentostatin. III. Characterize selected whole blood and blast cell metabolic parameters
serially in relation to cordycepin/pentostatin administration. IV. Measure and quantify any
clinical responses in refractory TdT positive leukemia patients following
cordycepin/pentostatin administration.
OUTLINE: This is a dose escalation study. Each treatment course is 28 days in length. On
days 1-3 pentostatin is administered over 5 minutes by IV bolus and followed 1 hour later by
a 1 hour infusion of cordycepin IV. An escalating dose of pentostatin is given with a fixed
dose of cordycepin until the desired level of adenosine deaminase inhibition is observed.
After this is determined, a dose escalation schedule for cordycepin is initiated to
determine the maximum tolerated dose (MTD) when given in combination with pentostatin. The
MTD is determined by the number of patients who exhibit dose limiting toxicity and the
severity of the toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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