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Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003005
First Posted: September 3, 2004
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Boston Medical Center
  Purpose

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 Intervention Phase
Leukemia Drug: Cordycepin Drug: Deoxycoformycin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Cordycepin (NSC 63984) Plus 2'-Deoxycoformycin (NSC 218321) in Patients With Refractory TdT-Positive Leukemia

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 28 days ]
    Dose limiting toxicities will be assessed within the first 28 days of study drug


Enrollment: 14
Study Start Date: December 1997
Study Completion Date: March 2001
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deoxycoformycin and cordycepin
Dose escalation for deoxycoformycin and cordycepin
Drug: Cordycepin

Dose escalation study using the following doses:

6mg/m2, 12 mg/m2, 24mg/m2, 48mg/m2

Drug: Deoxycoformycin
Dose escalation using the Fibonacci dose escalation sequence starting dose 2mg/m2, escalating to 3mg/m3 intravenous
Other Name: pentostatin, dCF

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003005


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

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00003005     History of Changes
Other Study ID Numbers: CDR0000065572
BUMC-4266
NCI-T96-0051
First Submitted: November 1, 1999
First Posted: September 3, 2004
Last Update Posted: June 13, 2012
Last Verified: June 2000

Keywords provided by Boston Medical Center:
recurrent adult acute lymphoblastic leukemia
blastic phase chronic myelogenous leukemia
TdT positive adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cordycepin
Pentostatin
Antineoplastic Agents
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents