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

NCT ID: NCT00038025

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-09-06
• Study Completion Date: 2006-11-29

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deoxycoformycin (DCF)/Pentostatin

Group Type: EXPERIMENTAL

Deoxycoformycin (DCF)

Intervention Type: DRUG

Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Nipent; Pentostatin

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Razelle Kurzrock, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson

Locations

M. D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

Public website for M. D. Anderson Cancer Center

Other Identifiers

DM94-026

Identifier Type: -

Identifier Source: org_study_id