NCT00098488

Brief Summary

This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given with or without rituximab in treating patients with relapsed B-cell chronic lymphocytic leukemia or prolymphocytic leukemia. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Monoclonal antibodies may kill cancer cells that are left after chemotherapy. Giving 17-N-allylamino-17-demethoxygeldanamycin with or without rituximab may kill more cancer cells.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

December 7, 2004

Last Update Submit

June 3, 2013

Conditions

B-cell Chronic Lymphocytic LeukemiaProlymphocytic LeukemiaRefractory Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)

    Defined at the dose level of 17-AAG at which 2 (or more) of 6 patients develop dose-limiting toxicity (DLT).

    Week 4

Secondary Outcomes (1)

  • Minimally effective pharmacological dose (MEPD) of 17-AAG based on down-modulation of the target protein Akt

    Day 1

Study Arms (1)

Treatment (17-AGG and rituximab)

EXPERIMENTAL

Patients receive 17-AAG IV over 2 hours on days 1, 4, 8, 11, 15 and 18 (course 1). Patients achieving ≥ 25% reduction in measurable disease after course 1 receive an additional course of single-agent 17-AAG approximately 10 days later in the absence of disease progression or unacceptable toxicity and provided absolute lymphocyte count continues to decrease. Patients failing to achieve a 25% reduction in measurable disease after course 1 OR with disease progression after courses 1 or 2 of single-agent 17-AAG proceed to combination therapy comprising 17-AAG IV over 2 hours on days 1, 4, 8, 11, 15, 18, and 22; and rituximab IV over 4 hours on days 1 and 2 and over 1 hour on days 4, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity.

Drug: tanespimycinBiological: rituximab

Interventions

tanespimycinDRUG

Given IV

Also known as: 17-AAG
Treatment (17-AGG and rituximab)
rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Treatment (17-AGG and rituximab)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed B-cell chronic lymphocytic leukemia or prolymphocytic leukemia requiring treatment, defined by 1 of the following criteria:
  • Massive or progressive splenomegaly and/or lymphadenopathy
  • Anemia (hemoglobin \< 11 g/dL) OR thrombocytopenia (platelet count \< 100,000/mm\^3)
  • Weight loss \> 10% within the past 6 months
  • Grade 2 or 3 fatigue
  • Fevers \> 100.5°F or night sweats for \> 2 weeks with no evidence of infection
  • Progressive lymphocytosis with an increase of \> 50% over a 2 month period OR an anticipated doubling time of \< 6 months
  • Relapsed disease
  • Failed prior fludarabine or pentostatin therapy OR cannot receive fludarabine
  • Lymphocyte count ≥ 5,000/mm\^3
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 12 weeks
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • +44 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Prolymphocytic

Interventions

tanespimycinRituximab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Thomas Lin

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

April 1, 2005

Primary Completion

April 1, 2008

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)