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CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Primary Purpose

Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temsirolimus
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Adult Diffuse Large Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of chronic lymphocytic leukemia (CLL) Relapsed, refractory, or transformed disease Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody Transformed CLL (Richters transformation), must meet both of the following criteria: Histologically confirmed lymphoma Measurable disease No CNS disease Performance status - ECOG 0-2 Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease) SGOT and SGPT < 3 times upper limit of normal Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present No history of allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779 No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness See Disease Characteristics No concurrent prophylactic hematopoietic colony-stimulating factors See Disease Characteristics More than 2 weeks since prior cytotoxic chemotherapy and recovered More than 2 weeks since prior radiotherapy and recovered No other concurrent investigational or antitumor agents No other concurrent cytotoxic agents No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (temsirolimus)

Arm Description

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.

Outcomes

Primary Outcome Measures

Response (CR or PR)
Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).

Secondary Outcome Measures

Full Information

First Posted
July 8, 2004
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00086840
Brief Title
CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official Title
A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
May 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory chronic lymphocytic leukemia. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description
OBJECTIVES: I. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed chronic lymphocytic leukemia. OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic lymphocytic leukemia [CLL] vs transformed CLL). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (temsirolimus)
Arm Type
Experimental
Arm Description
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.
Intervention Type
Drug
Intervention Name(s)
temsirolimus
Other Intervention Name(s)
CCI-779, cell cycle inhibitor 779, Torisel
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response (CR or PR)
Description
Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of chronic lymphocytic leukemia (CLL) Relapsed, refractory, or transformed disease Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody Transformed CLL (Richters transformation), must meet both of the following criteria: Histologically confirmed lymphoma Measurable disease No CNS disease Performance status - ECOG 0-2 Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease) SGOT and SGPT < 3 times upper limit of normal Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present No history of allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779 No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness See Disease Characteristics No concurrent prophylactic hematopoietic colony-stimulating factors See Disease Characteristics More than 2 weeks since prior cytotoxic chemotherapy and recovered More than 2 weeks since prior radiotherapy and recovered No other concurrent investigational or antitumor agents No other concurrent cytotoxic agents No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Giles
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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