NCT00005982

Brief Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

July 5, 2000

Last Update Submit

January 22, 2013

Conditions

Recurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Response rate (RR) defined as CR + PR rates

    Up to 4 years

Study Arms (1)

Treatment (nelarabine)

EXPERIMENTAL

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: nelarabineOther: pharmacological study

Interventions

nelarabineDRUG

Given IV

Also known as: 506U78, Arranon, GW506U78
Treatment (nelarabine)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (nelarabine)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
  • Large cell transformation of cutaneous T-cell lymphoma allowed
  • No active CNS disease
  • Performance status - Zubrod 0-2
  • Absolute neutrophil count at least 1,000/mm\^3\*
  • Platelet count at least 100,000/mm\^3\*
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGPT no greater than 2.5 times ULN
  • Creatinine clearance greater than 50 mL/min
  • No history of symptomatic cardiac dysfunction
  • No history of pericardial effusion
  • HIV negative
  • No grade 2 or greater sensory or motor neuropathy
  • No history of seizures
  • No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Interventions

nelarabine

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andre Goy

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Primary Completion

July 1, 2004

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)