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CCI-779 and Rituximab in Trea...

CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Last Updated: 2014-04-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2012-03-31

Brief Summary

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This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells

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Detailed Description

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PRIMARY OBJECTIVES:

I. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab.

II. Determine the tolerability of this regimen in these patients by assessing toxicity.

SECONDARY OBJECTIVES:

I. Determine the time to disease progression and overall survival of patients treated with this regimen.

II. Determine the duration of response in patients treated with this regimen.

OUTLINE: Patients are stratified according to prior response to rituximab (sensitive \[partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last treatment with rituximab alone or in combination with chemotherapy\] vs refractory \[stable or progressive disease OR a PR or CR that lasted \< 6 months after the last treatment with rituximab alone or in combination with chemotherapy\]).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

After completion of study treatment, 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.

Conditions

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Recurrent Mantle Cell Lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

375 mg/m\^2 Given IV

temsirolimus

Intervention Type DRUG

25 mg given IV

Interventions

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rituximab

375 mg/m\^2 Given IV

Intervention Type BIOLOGICAL

temsirolimus

25 mg given IV

Intervention Type DRUG

Other Intervention Names

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IDEC-C2B8 IDEC-C2B8 monoclonal antibody Mabthera MOAB IDEC-C2B8 Rituxan CCI-779 cell cycle inhibitor 779 Torisel

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed\* mantle cell lymphoma (MCL)

* Relapsed, refractory, or stable disease after prior treatment
* Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
* Measurable disease, defined as ≥ 1 of the following:

* Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
* Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
* Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
* No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
* Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
* At least 3 months
* No other concurrent treatment for MCL
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Direct bilirubin \< 1.5 times ULN
* Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)
* Creatinine ≤ 2 times ULN
* 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 during and for 3 months after completion of study treatment
* Cholesterol ≤ 350 mg/dL
* Fasting triglycerides \< 400 mg/dL
* No known HIV positivity
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs
* Prior biologic response modifiers allowed
* Prior immunotherapy allowed
* Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed
* No concurrent prophylactic growth factor to support neutrophils
* Prior chemotherapy allowed
* No other concurrent chemotherapy
* No concurrent corticosteroids to induce an antitumor response

* Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed
* Prior radiotherapy allowed
* No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor
* No other concurrent investigational or commercial agents or therapies for MCL
* No other concurrent immunosuppressive therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Ansell

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Saint Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program CCOP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Carle Foundation dba Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Francis Hospital and Health Centers

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Center

Michigan City, Indiana, United States

Site Status

Reid Hospital and Health Care Services

Richmond, Indiana, United States

Site Status

McFarland Clinic

Ames, Iowa, United States

Site Status

Saint Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Association

Cedar Rapids, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates

Cedar Rapids, Iowa, United States

Site Status