Evanston, Illinois 60201

  • Lymphoma

Purpose:

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.


Criteria:

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:

CDR0000365314


NCT ID:

NCT00084474


Secondary ID:

UCCRC-12983A


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:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

106


Enrollment Type:

Anticipated


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
Measure:Safety
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Toxicity
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:temsirolimus

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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.