Evanston, Illinois 60201

  • Lymphoma


RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: 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.

Study summary:

OBJECTIVES: - 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. - Determine the toxicity and safety of this drug in these patients. - Correlate the degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in patients treated with this drug. - Correlate CCI-779 induced inactivation of mTOR with response in these patients. OUTLINE: This is a multicenter study. 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. PROJECTED ACCRUAL: A total of 47-106 patients (13-32 for the aggressive lymphoma stratum and 17-37 each for the other 2 strata) will be accrued for this study within 21-24 months.


DISEASE CHARACTERISTICS: - 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 - 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 - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count ≥ 1,000/mm^3 - Platelet count ≥ 50, 000/mm^3 (> 20,000/mm^3 for patients with thrombocytopenia due to bone marrow involvement) Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 2.5 times ULN Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - 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 - Fasting cholesterol ≤ 350 mg/dL - Fasting triglycerides ≤ 400 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No concurrent prophylactic hematopoietic colony-stimulating factors - No concurrent pegfilgrastim Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - 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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

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Reasons Why Stopped:

Study Type:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Sonali M. Smith, MD
Principal Investigator
University of Chicago

Study Dates

Start Date:March 2004
Primary Completion Date:April 2010
Primary Completion Type:Actual
Verification Date:October 2007
Last Changed Date:February 19, 2012
First Received Date:June 10, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Objective overall response rate
Safety Issues:False
Outcome Type:Secondary Outcome
Safety Issues:True
Outcome Type:Secondary Outcome
Safety Issues:True

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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