NCT00082966

Brief Summary

Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

December 4, 2015

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

May 14, 2004

Last Update Submit

December 3, 2015

Conditions

Adult Lymphocyte Depletion Hodgkin LymphomaAdult Mixed Cellularity Hodgkin LymphomaAdult Nodular Sclerosis Hodgkin LymphomaRecurrent Adult Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

  • Overall response rate

    Up to 3 years

  • Time to progression

    Up to 5 years

  • Overall survival

    2 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.

Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib

Interventions

17-N-allylamino-17-demethoxygeldanamycin/bortezomibDRUG

Given IV

Arm I

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed classical Hodgkin's lymphoma
  • No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis
  • Core biopsies allowed if they contain adequate tissue for primary diagnosis
  • The following subtypes are allowed:
  • Nodular sclerosis
  • Lymphocyte rich
  • Mixed cellularity
  • Lymphocyte depletion
  • Classical Hodgkin's lymphoma, not otherwise specified
  • No nodular lymphocyte-predominant Hodgkin's lymphoma
  • Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen
  • Measurable disease by physical exam or imaging studies
  • Any tumor mass \> 1 cm is allowed
  • No non-measurable disease only, including the following:
  • Bone lesions
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

tanespimycinBortezomib

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nancy Bartlett

    Cancer and Leukemia Group B

    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

May 14, 2004

First Posted

May 17, 2004

Study Start

March 1, 2004

Primary Completion

March 1, 2007

Last Updated

December 4, 2015

Record last verified: 2013-06

Locations

US(1)