NCT00006473

Brief Summary

Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Trial Health

80
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-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 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

5.4 years

First QC Date

November 6, 2000

Last Update Submit

January 22, 2013

Conditions

Angioimmunoblastic T-cell LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic LymphomaWaldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Using a Simon's two-stage model.

    Up to 6 years

Secondary Outcomes (1)

  • Duration of response

    Up to 6 years

Study Arms (1)

Treatment (oxaliplatin)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatin

Interventions

oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Treatment (oxaliplatin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype
  • Indolent
  • Follicular small cleaved cell
  • Follicular mixed cell
  • Small lymphocytic
  • Mucosa-associated lymphoid tissue (MALT)
  • Monocytoid B-cell
  • Waldenstrom's macroglobulinemia
  • Aggressive
  • Follicular large cell
  • Diffuse large cell
  • Immunoblastic
  • Mantle cell
  • Ki-1+ NHL
  • Peripheral T-cell
  • +31 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

Immunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom Macroglobulinemia

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

LymphadenopathyLymphatic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Anas Younes

    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

November 6, 2000

First Posted

January 27, 2003

Study Start

September 1, 2000

Primary Completion

February 1, 2006

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)