Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/11/2018
Start Date:April 2009
End Date:June 15, 2017

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Phase I/II Trial of Rituximab, Cladribine, and Temsirolimus (RCT) Therapy in Newly Diagnosed Mantle Cell Lymphoma (MCL)

This phase I/II trial studies the side effects and best dose of temsirolimus when given
together with cladribine and rituximab and to see how well it works in treating patients with
newly diagnosed mantle cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere
with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as
cladribine, work in different ways to stop the growth of cancer cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may
stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Giving temsirolimus together with cladribine and rituximab may kill more cancer cells.

PRIMARY OBJECTIVES:

I. To assess the efficacy and safety of the combination of rituximab, cladribine, and
temsirolimus for newly diagnosed mantle cell lymphoma.

II. To determine the maximum tolerated dose (MTD) of temsirolimus combined with a fixed dose
and schedule of rituximab and cladribine. (Phase I) III. To assess the efficacy of the
combination of rituximab, cladribine, and temsirolimus for newly diagnosed mantle cell
lymphoma with the proportion of complete responses as the primary endpoint. (Phase II)

SECONDARY OBJECTIVES:

I. To assess other measures of efficacy of the regimen including progression free survival,
duration of response, and overall survival.

II. To assess the toxicity profile of the combination of rituximab, cladribine, and
temsirolimus.

III. To assess efficacy using traditional lymphoma parameters and absolute lymphocyte count.

IV. To assess metabolic markers (hyperglycemia, hyperlipidemia) as markers of mammalian
target of rapamycin (mTOR) inhibition using the glucose and lipid measurements being
performed in the clinical laboratory as part of routine care.

V. To correlate response with serum free light chains, single nucleotide polymorphisms (SNPs)
in host immune genes, vitamin D metabolites, and phosphatidylinositide 3-kinase (PI3K)
pathway member expression.

VI. As part of ongoing research for North Central Cancer Treatment Group (NCCTG) lymphoma
studies, paraffin-embedded tissue blocks/slides and blood products will be banked for future
studies.

OUTLINE: This is a phase I, dose-escalation study of temsirolimus followed by a phase II
study.

Patients receive rituximab intravenously (IV) on day 1 and cladribine IV over 2 hours on days
1-5. Patients then receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Patients
also receive filgrastim subcutaneously (SC) on days 6-15 or pegfilgrastim SC on day 6.
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 4 months for 3 years.

Inclusion Criteria:

- Histologically confirmed mantle cell lymphoma (MCL); the diagnosis must be confirmed
by NCCTG pre-registration pathology review by Dr. Paul Kurtin or his designate; it is
recommended that the biopsy be an excisional biopsy, but adequate core-needle biopsies
will be accepted as long as they are considered adequate for registration by Dr.
Kurtin or his designate; the tumor must be cyclin D-1 positive by immunohistochemistry
or have evidence of a t(11;14) translocation by fluorescence based in situ
hybridization (FISH) or cytogenetics

- Measurable or assessable disease, defined as at least one of the following:

- A lymph node or tumor mass that is >= 2.0 cm in at least one dimension by
positron emission tomography (PET)/computed tomography (CT), CT, magnetic
resonance imaging (MRI), or plain radiograph imaging

- Splenic enlargement may be used as a measurable parameter if the spleen is
palpable >= 3 cm below the left costal margin

- Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral
blood, liver, lungs, or bowel by lymphoma without a discrete mass would
constitute assessable, but not measurable, disease

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3

- Life expectancy >= 12 weeks

- Absolute neutrophil count (ANC) >= 1,500/mm³

- Platelet count (PLT) >= 100,000/mm³

- Serum creatinine =< 2.0 mg/dL

- Serum total bilirubin (or direct bilirubin if total is abnormal) =< institutional
upper limit of normal (ULN) with or without secondary liver involvement

- Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x institutional ULN (exception: if
there is liver involvement, SGOT must be =< 5 x institutional ULN)

- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- Willingness to return to NCCTG enrolling institution for follow-up

- Willingness to provide the blood specimens as required by the protocol

- Willingness to provide tissue specimens as required by the protocol

- Willing to return to NCCTG enrolling institution for follow-up

- Willing to provide blood and tissue specimens as required by the protocol

- Willing to abstain from eating grapefruit or drinking grapefruit juice

- Willingness to abstain from eating grapefruit or drinking grapefruit juice for the
duration of the study

Exclusion Criteria

- Any prior therapy for mantle cell non-Hodgkin lymphoma including radiation therapy;
exception: patient may have undergone a splenectomy for diagnosis, cytopenia, or
systematic splenomegaly

- Active or uncontrolled infection

- Any of the following cardiac conditions:

- Uncontrolled high blood pressure

- Unstable angina

- Active congestive heart failure

- Myocardial infarction =< 6 months

- Serious uncontrolled cardiac arrhythmia

- Known central nervous system (CNS) involvement

- Any of the following:

- Pregnant women or women of reproductive ability who are unwilling to use
effective contraception while taking the drug and for 12 months after stopping
treatment

- Nursing women

- Men who are unwilling to use a condom (even if they have undergone a prior
vasectomy) while having intercourse with any woman, while taking the drug and for
12 months after stopping treatment

- Medical or psychiatric conditions which, in the opinion of the investigator, make the
patient a poor risk for participation

- Known to be human immunodeficiency virus (HIV) positive; HIV testing is not required
but should be done if clinically indicated; HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study

- Concurrent malignancy =< 5 years ago; exceptions: carcinoma in situ of the cervix,
resected basal cell or squamous cell carcinomas of the skin, or prostate cancer that
is in remission following a radical retropubic prostatectomy or radiation therapy; if
there is a history of prior malignancy, they must not be receiving other specific
treatment (other than hormonal therapy) for their cancer

- Known hypersensitivity to rituximab or its components, or to murine proteins

- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm

- Prior treatment with an mTOR inhibitor

- Autologous or allogeneic stem cell transplant planned as part of initial therapy

- Receiving enzyme-inducing antiepileptic drugs (enzyme inducing anti-epileptic drugs
[EIAEDs]; e.g., phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, phenobarbital,
or primidone); any other potent cytochrome P450, family 3, subfamily A, polypeptide 4
(CYP3A4) inducer such as rifampin, glucocorticoids at greater than adrenal replacement
levels, or St. John's wort; or receiving strong CYP3A4 inhibitors * Note: if these
agents are discontinued, temsirolimus therapy can begin >= 7 days after
discontinuation of such agent
We found this trial at
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825 N Emporia Ave
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300 North Ave
Battle Creek, Michigan 49017
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605 Oak St
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Mecosta County Medical Center Spectrum Health is a not-for-profit system of care dedicated to improving...
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Billings, Montana 59101
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2900 12th Ave N Ste 160W
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100 Michigan Street, NE, MC012
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1007 LINCOLNWAY
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Newton, Kansas 67114
(316) 282-0888
Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Newton, KS
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4 Longmeadow Village Dr
Niles, Michigan 49120
(269) 683-4153
Michiana Hematology Oncology PC - Niles In 1968, medical oncologist Thomas Troeger, MD had a...
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Niles, MI
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Normal, Illinois 61761
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Normal, IL
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407 East Vernon Ave.
Normal, Illinois 61761
(309) 451-8500
Illinois CancerCare - Community Cancer Center At the Community Cancer Center, we are committed to...
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Normal, IL
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407 East Vernon Ave.
Normal, Illinois 61761
(309) 451-8500
Illinois CancerCare - Community Cancer Center At the Community Cancer Center, we are committed to...
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Normal, IL
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1304 Franklin Avenue
Normal, Illinois 61761
309.454.1400
BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
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Normal, IL
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Oconto Falls, Wisconsin 54154
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Oconto Falls, WI
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Ottawa, IL
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1100 East Norris Drive
Ottawa, Illinois 61350
(815) 433-3100
Community Hospital of Ottawa Ottawa Regional Hospital, an acute care medical facility, is located on...
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Ottawa, IL
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1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Parsons, KS
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603 S 13th St
Pekin, Illinois 61554
(309) 353-0214
Illinois CancerCare - Pekin Illinois CancerCare is one of the largest private oncology and hematology...
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Pekin, IL
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603 S 13th St
Pekin, Illinois 61554
(309) 353-0512
Cancer Treatment Center at Pekin Hospital Since 1913, Pekin Hospital has been dedicated to improving...
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Pekin, IL
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