A Study Of Deoxycoformycin(DCF)/Pentost… | Clinical Trial

Key information

Conditions

Peripheral T-cell Lymphoma Chronic Disease Chronic Lymphocytic Leukemia Cutaneous T-Cell Lymphoma Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deoxycoformycin (DCF)

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.

Other names: Nipent, Pentostatin

Primary outcomes

Number of Participants with Overall Response

Time frame: 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).

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 1994
Primary completion: 2006
Study completion: 2006
First posted: May 27, 2002
Registry last updated: Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed