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

Phase 2

Completed

• Conditions: Cutaneous T-cell Lymphoma; Chronic Lymphocytic Leukemia; Peripheral T-cell Lymphoma
• Interventions: Drug: Deoxycoformycin (DCF)

• Registration Number: NCT00038025
• Lead Sponsor: M.D. Anderson Cancer Center

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 Timeline

• Study Start: 1994-09-06
• Study First Submitted: 2002-05-24
• Study First Submitted QC: 2002-05-24
• Study First Posted: 2002-05-27
• Primary Completion: 2006-11-29
• Study Completion: 2006-11-29
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deoxycoformycin (DCF)/Pentostatin	Deoxycoformycin (DCF)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Overall Response	Baseline and approximately every 3 weeks thereafter	Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).

Trial Locations

Locations (1)

M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States