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CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

Primary Purpose

Recurrent Mantle Cell Lymphoma

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

About this trial

This is an interventional treatment trial for Recurrent Mantle Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria: 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) Direct bilirubin ≤ 1.5 times ULN AST ≤ 3 times ULN (5 times ULN if liver metastases are present) Creatinine ≤ 2 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Cholesterol ≤ 350 mg/dL Triglycerides ≤ 400 mg/dL HIV negative No other active malignancy requiring treatment or that would preclude study participation No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation See Disease Characteristics Prior high-dose therapy with stem cell transplantation allowed At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers See Disease Characteristics See Biologic therapy At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy for MCL Concurrent corticosteroids for adrenal insufficiency allowed See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent radiotherapy for MCL Any number of prior treatments allowed No other concurrent investigational or commercial agents for MCL No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide) No concurrent immunosuppressive therapies

Sites / Locations

  • North Central Cancer Treatment Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Overall survival
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Progression-free survival
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Duration of response

Full Information

First Posted
April 9, 2002
Last Updated
April 2, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033267
Brief Title
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
Official Title
A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Determine the objective responses in patients with previously treated mantle cell non-Hodgkin's lymphoma treated with CCI-779. II. Determine the toxic effects of this drug in these patients. III. Determine whether this drug inhibits cell proliferation pathways in these patients. OUTLINE: 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 complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Mantle Cell Lymphoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
temsirolimus
Other Intervention Name(s)
CCI-779, cell cycle inhibitor 779, Torisel
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
Description
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.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Time to progression
Description
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to the time of progression, assessed up to 5 years
Title
Overall survival
Description
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to death due to any cause, assessed up to 5 years
Title
Progression-free survival
Description
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to progression or death due to any cause, assessed up to 5 years
Title
Duration of response
Time Frame
From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Direct bilirubin ≤ 1.5 times ULN AST ≤ 3 times ULN (5 times ULN if liver metastases are present) Creatinine ≤ 2 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Cholesterol ≤ 350 mg/dL Triglycerides ≤ 400 mg/dL HIV negative No other active malignancy requiring treatment or that would preclude study participation No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation See Disease Characteristics Prior high-dose therapy with stem cell transplantation allowed At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers See Disease Characteristics See Biologic therapy At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy for MCL Concurrent corticosteroids for adrenal insufficiency allowed See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent radiotherapy for MCL Any number of prior treatments allowed No other concurrent investigational or commercial agents for MCL No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide) No concurrent immunosuppressive therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Ansell
Organizational Affiliation
North Central Cancer Treatment Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Central Cancer Treatment Group
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

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