Clinical trial NCT00033267: CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
Official title: A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Mantle Cell Lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Detailed description: OBJECTIVES:

I. Determine the objective responses in patients with previously treated mantle cell non-Hodgkin's lymphoma treated with CCI-779.

II. Determine the toxic effects of this drug in these patients. III. Determine whether this drug inhibits cell proliferation pathways in these patients.

OUTLINE:

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 with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with complete response (CR) receive 2 additional courses beyond CR.

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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)
* Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy
* Unidimensionally measurable lymph node or lesion

  * At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam
  * One of the following measurement parameters may be used:

    * Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
    * Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm\^3
* No known CNS involvement (parenchymal mass or leptomeningeal involvement)
* Performance status - ECOG 0-2
* At least 3 months
* See Disease Characteristics
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Direct bilirubin ≤ 1.5 times ULN
* AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
* Creatinine ≤ 2 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Cholesterol ≤ 350 mg/dL
* Triglycerides ≤ 400 mg/dL
* HIV negative
* No other active malignancy requiring treatment or that would preclude study participation
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* See Disease Characteristics
* Prior high-dose therapy with stem cell transplantation allowed
* At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers
* See Disease Characteristics
* See Biologic therapy
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No other concurrent chemotherapy for MCL
* Concurrent corticosteroids for adrenal insufficiency allowed
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* No concurrent radiotherapy for MCL
* Any number of prior treatments allowed
* No other concurrent investigational or commercial agents for MCL
* No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide)
* No concurrent immunosuppressive therapies

Primary outcomes:
measure: Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Time to progression
timeFrame: Time from registration to the time of progression, assessed up to 5 years
measure: Overall survival
timeFrame: Time from registration to death due to any cause, assessed up to 5 years
measure: Progression-free survival
timeFrame: Time from registration to progression or death due to any cause, assessed up to 5 years
measure: Duration of response
timeFrame: From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: North Central Cancer Treatment Group
state: Minnesota
Study officials:
affiliation: North Central Cancer Treatment Group
name: Stephen Ansell
role: PRINCIPAL_INVESTIGATOR
References: