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A Phase I Study of Cordycepin (NSC 63984) Plus 2'-Deoxycoformycin (NSC 218321) in Patients With Refractory TdT-Positive Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase I Study of Cordycepin (NSC 63984) Plus 2'-Deoxycoformycin (NSC 218321) in Patients With Refractory TdT-Positive 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.

Inclusion Criteria


DISEASE CHARACTERISTICS: TdT positive acute lymphocytic leukemia or blastic chronic
myelogenous leukemia Failed at least one standard treatment

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 2.0 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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Description:

Dose limiting toxicities will be assessed within the first 28 days of study drug

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Timothy J. Ernst, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000065572

NCT ID:

NCT00003005

Start Date:

December 1997

Completion Date:

March 2001

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • blastic phase chronic myelogenous leukemia
  • TdT positive adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
New England Medical Center HospitalBoston, Massachusetts  02111
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Boston Medical CenterBoston, Massachusetts  02118
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110
Brigham and Women's HospitalBoston, Massachusetts  02115