A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies - Tabular View

Tracking Information

First Received Date ^ICMJE

May 24, 2002

Last Updated Date

July 6, 2009

Start Date ^ICMJE

September 1994

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin. [ Time Frame: Baseline and approximately every 3 weeks thereafter ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00038025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies

Official Title ^ICMJE

A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies

Brief Summary

The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.

Detailed Description

Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Peripheral T-Cell Lymphoma
Cutaneous T-Cell Lymphoma
Chronic Lymphocytic Leukemia

Intervention ^ICMJE

Drug: Deoxycoformycin (DCF)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologic proof of lymphoid malignancy with an expected complete response rate of less than 20 percent OR have failed at least one prior therapy.
No chemotherapy within 3 weeks of entry into study and must have recovered from acute toxic effects of prior therapy.
Life expectancy of at least 12 weeks.
Performance status equal to or less than Zubrod 2.
Signed informed consent.
Patients with measurable disease.
Age at least 16 years.
Adequate bone marrow function (unless involvement of bone marrow by lymphoma) defined as AGC greater than 1500 and platelet count greater than 100,000.
Adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and SGPT less than or equal to 4 times the upper limits of normal.
Adequate renal function defined as serum creatine less than or equal to 1.5 mg %.

Exclusion Criteria:

No serious intercurrent illness.
Adequate contraception (if applicable).
NO patients with significant cardiac disease, i.e. NYHA class III or IV.
NO experimental clinical trial within 3 weeks of study entry.
NO patients with active CNS disease.
Full recovery from any prior surgical treatment.
NO active active infections.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00038025

Responsible Party

Razelle Kurzrock, MD, BS / Professor, UT MD Anderson Cancer Center

Study ID Numbers ^ICMJE

DM94-026

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Razelle Kurzrock, MD

MD Anderson

Information Provided By

M.D. Anderson Cancer Center

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP