Brief Title
CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Official Title
A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
Brief Summary
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from
dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works
in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic
lymphocytic leukemia.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the complete and partial response rate in patients with recurrent or refractory
B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779.
II. Determine the toxicity and safety of this drug in these patients. III. Correlate the
degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in
patients treated with this drug.
IV. Correlate CCI-779 induced inactivation of mTOR with response in these patients.
OUTLINE: Patients are stratified according to disease (aggressive lymphoma [group A] vs
follicular lymphoma [group B] vs small lymphocytic lymphoma or chronic lymphocytic leukemia
[group C]).
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 are followed every 8 weeks.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Overall Response Rate
Condition
B-cell Chronic Lymphocytic Leukemia
Intervention
temsirolimus
Study Arms / Comparison Groups
Arm I
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 are followed every 8 weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
89
Start Date
March 2004
Completion Date
April 2010
Primary Completion Date
April 2010
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including the
following subtypes:
- Aggressive B-cell lymphoma (Group A)
- Diffuse large B-cell lymphoma
- Transformed lymphoma
- Follicular lymphoma (Group B)
- Small lymphocytic lymphoma
- Chronic lymphocytic leukemia (CLL) (Group C)
- Other B-cell small lymphocytic disorders
- No mantle cell lymphoma
- No potentially curative treatment options because of lack of response, relapse, or
ineligibility
- Relapsed or refractory disease
- Patients with refractory disease (i.e., less than a partial response to the last
treatment) must have received no more than 3 prior regimens (group A)
- Patients with sensitive disease (i.e., at least a partial response to the last
treatment) must have received no more than 4 prior regimens (group A)
- Patients who have failed prior autologous transplantation are eligible (group A)
- No more than 5 prior regimens (groups B and C)
- The salvage regimen, conditioning regimen, and any maintenance therapy are
considered 1 regimen
- Prior rituximab or alemtuzumab is not considered prior therapy
- No limitation to the amount of prior radiotherapy
- No CNS involvement
- Performance status: ECOG 0-2 OR Karnofsky 60-100%
- Life expectancy more than 3 months
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No prior 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 active malignancy except nonmelanoma skin cancer or carcinoma in situ of the
cervix Completed therapy and considered < 30% risk of relapse
- No other concurrent uncontrolled illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent prophylactic hematopoietic colony-stimulating factors
- No concurrent pegfilgrastim
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent unconventional therapies, food, or vitamin supplements containing
Hypericum perforatum (St. John's wort)
- No other concurrent known inducers of CYP3A4
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- Measurable disease*
- At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques
OR >= 10 mm by spiral CT scan [Note: *Only bone marrow or peripheral blood
involvement required for CLL and Waldenstrom's macroglobulinemia ]
- Absolute neutrophil count >= 1,000/mm3
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- AST and ALT =< 2.5 times ULN
- Creatinine =< 1.5 times ULN
- Fasting cholesterol =< 350 mg/dL
- Fasting triglycerides =< 400 mg/dL
- Platelet count >= 50, 000/mm3 (> 20,000/mm3 for patients with thrombocytopenia due to
bone marrow involvement)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sonali Smith, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00290472
Organization ID
NCI-2009-00047
Secondary IDs
NCI-2009-00047
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Sonali Smith, Principal Investigator, University of Chicago
Verification Date
February 2013