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.

Condition	Treatment or Intervention	Phase
recurrent adult acute lymphocytic leukemia TdT positive adult acute lymphocytic leukemia blastic phase chronic myelogenous leukemia	Drug: cordycepin  Drug: pentostatin	Phase I

Further Study Details: 

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.

PROTOCOL OUTLINE: This is a dose escalation study.

Each treatment cycle 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• TdT positive acute lymphocytic leukemia or blastic chronic myelogenous leukemia
• Failed at least one standard treatment

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 3 weeks since chemotherapy; No concurrent chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: At least 3 weeks since radiation therapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky greater than 70%
• Life expectancy: At least 3 months
• Hematopoietic: Not specified
• Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 2.5 times normal
• Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance greater than 60 mL/min
• Cardiovascular: Ejection fraction greater than 40%
• Other: Not pregnant or nursing; No serious concurrent illness

District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States
Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Missouri
      Washington University Barnard Cancer Center, Saint Louis,  Missouri,  63110,  United States
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
Oregon
      Oregon Cancer Center at Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States

Study chairs or principal investigators

Timothy Jon Ernst,  Study Chair,  Boston Medical Center   

Study ID Numbers:  CDR0000065572; BUMC-4266; NCI-T96-0051
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003005
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08