NCT00038025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 1994

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 1994

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2002

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2006

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

12.2 years

First QC Date

May 24, 2002

Last Update Submit

November 14, 2018

Conditions

Peripheral T-cell LymphomaCutaneous T-cell LymphomaChronic Lymphocytic Leukemia

Keywords

Mycosis FungoidesLymphomaChronic lymphocytic leukemiaDeoxycoformycinPentostatinAll other lymphomasNucleoside analogueAdenosine deaminase inhibitorT-cells

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline and approximately every 3 weeks thereafter

Study Arms (1)

Deoxycoformycin (DCF)/Pentostatin

EXPERIMENTAL
Drug: Deoxycoformycin (DCF)

Interventions

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.

Also known as: Nipent, Pentostatin
Deoxycoformycin (DCF)/Pentostatin

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 %.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, CutaneousLeukemia, Lymphocytic, Chronic, B-CellMycosis FungoidesLymphoma

Interventions

Pentostatin

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Razelle Kurzrock, MD

    MD Anderson

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2002

First Posted

May 27, 2002

Study Start

September 6, 1994

Primary Completion

November 29, 2006

Study Completion

November 29, 2006

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

US(1)