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

Primary Purpose

Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Deoxycoformycin (DCF)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Mycosis Fungoides, Lymphoma, Chronic lymphocytic leukemia, Deoxycoformycin, Pentostatin, All other lymphomas, Nucleoside analogue, Adenosine deaminase inhibitor, T-cells

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M. D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deoxycoformycin (DCF)/Pentostatin

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants with Overall Response
Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).

Secondary Outcome Measures

Full Information

First Posted
May 24, 2002
Last Updated
November 14, 2018
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00038025
Brief Title
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
Official Title
A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 6, 1994 (Actual)
Primary Completion Date
November 29, 2006 (Actual)
Study Completion Date
November 29, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, Chronic Lymphocytic Leukemia
Keywords
Mycosis Fungoides, Lymphoma, Chronic lymphocytic leukemia, Deoxycoformycin, Pentostatin, All other lymphomas, Nucleoside analogue, Adenosine deaminase inhibitor, T-cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deoxycoformycin (DCF)/Pentostatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Deoxycoformycin (DCF)
Other Intervention Name(s)
Nipent, Pentostatin
Intervention Description
Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.
Primary Outcome Measure Information:
Title
Number of Participants with Overall Response
Description
Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).
Time Frame
Baseline and approximately every 3 weeks thereafter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Razelle Kurzrock, MD
Organizational Affiliation
MD Anderson
Official's Role
Principal Investigator
Facility Information:
Facility Name
M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
Public website for M. D. Anderson Cancer Center

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

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