NCT00003005

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Dec 1997

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

September 3, 2004

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2000

Enrollment Period

3.2 years

First QC Date

November 1, 1999

Last Update Submit

June 12, 2012

Conditions

Leukemia

Keywords

recurrent adult acute lymphoblastic leukemiablastic phase chronic myelogenous leukemiaTdT positive adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

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

    28 days

Study Arms (1)

deoxycoformycin and cordycepin

EXPERIMENTAL

Dose escalation for deoxycoformycin and cordycepin

Drug: CordycepinDrug: Deoxycoformycin

Interventions

CordycepinDRUG

Dose escalation study using the following doses: 6mg/m2, 12 mg/m2, 24mg/m2, 48mg/m2

deoxycoformycin and cordycepin
DeoxycoformycinDRUG

Dose escalation using the Fibonacci dose escalation sequence starting dose 2mg/m2, escalating to 3mg/m3 intravenous

Also known as: pentostatin, dCF
deoxycoformycin and cordycepin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaBlast Crisis

Interventions

cordycepinPentostatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Timothy J. Ernst, MD

    Boston Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 3, 2004

Study Start

December 1, 1997

Primary Completion

March 1, 2001

Study Completion

March 1, 2001

Last Updated

June 13, 2012

Record last verified: 2000-06

Locations

US(13)