NCT00033267

Brief Summary

Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2002

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

April 1, 2002

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months 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
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 3, 2014

Status Verified

December 1, 2012

Enrollment Period

3.8 years

First QC Date

April 9, 2002

Last Update Submit

April 2, 2014

Conditions

Recurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria

    The proportion will be evaluated separately for each dose group. The proportion of patients who achieve a confirmed CR or PR, or success, will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Up to 24 weeks

Secondary Outcomes (4)

  • Time to progression

    Time from registration to the time of progression, assessed up to 5 years

  • Overall survival

    Time from registration to death due to any cause, assessed up to 5 years

  • Progression-free survival

    Time from registration to progression or death due to any cause, assessed up to 5 years

  • Duration of response

    From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with CR receive 2 additional courses beyond CR.

Drug: temsirolimus

Interventions

temsirolimusDRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel
Treatment

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)
  • Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy
  • Unidimensionally measurable lymph node or lesion
  • At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam
  • One of the following measurement parameters may be used:
  • Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
  • Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm\^3
  • No known CNS involvement (parenchymal mass or leptomeningeal involvement)
  • Performance status - ECOG 0-2
  • At least 3 months
  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm\^3
  • Platelet count ≥ 75,000/mm\^3
  • Hemoglobin ≥ 8 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

temsirolimusSirolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Stephen Ansell

    North Central Cancer Treatment Group

    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

April 9, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Primary Completion

February 1, 2006

Study Completion

February 1, 2008

Last Updated

April 3, 2014

Record last verified: 2012-12

Locations

US(1)