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

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038025

Purpose

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

Condition	Intervention	Phase
Peripheral T-cell Lymphoma Cutaneous T-cell Lymphoma Chronic Lymphocytic Leukemia	Drug: Deoxycoformycin (DCF)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma

Drug Information available for: Adenosine Pentostatin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Participants with Overall Response [ Time Frame: Baseline and approximately every 3 weeks thereafter ] [ Designated as safety issue: No ]
Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).

Enrollment:	60
Study Start Date:	September 1994
Study Completion Date:	November 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Deoxycoformycin (DCF)/Pentostatin	Drug: Deoxycoformycin (DCF) Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals. Other Names: Nipent Pentostatin

Detailed Description:

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

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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. New York Heart Association (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038025

Locations

United States, Texas
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Razelle Kurzrock, MD

MD Anderson

More Information

Additional Information:

Public website for M. D. Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Razelle Kurzrock, MD, BS / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038025 History of Changes
Other Study ID Numbers:	DM94-026
Study First Received:	May 24, 2002
Last Updated:	April 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Mycosis Fungoides
Lymphoma
Chronic lymphocytic leukemia
Deoxycoformycin
Pentostatin

All other lymphomas
Nucleoside analogue
Adenosine deaminase inhibitor
T-cells

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Pentostatin
Adenosine Deaminase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012