CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title:

A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033267
• Other study ID #: NCI-2012-01870
• Secondary ID: NCI-2012-01870NC
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2002
• Last updated: April 2, 2014
• Start date: April 2002
• Est. completion date: February 2008

Study information

• Verified date: December 2012
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2008
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Recurrent Mantle Cell Lymphoma

Intervention

Drug:
• temsirolimus
Given IV

Locations

Country	Name	City	State
United States	North Central Cancer Treatment Group	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria	The proportion will be evaluated separately for each dose group. The proportion of patients who achieve a confirmed CR or PR, or success, will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.	Up to 24 weeks	No
Secondary	Time to progression	The distribution of time to progression will be estimated using the method of Kaplan-Meier.	Time from registration to the time of progression, assessed up to 5 years	No
Secondary	Overall survival	The distribution of overall survival will be estimated using the method of Kaplan-Meier.	Time from registration to death due to any cause, assessed up to 5 years	No
Secondary	Progression-free survival	The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.	Time from registration to progression or death due to any cause, assessed up to 5 years	No
Secondary	Duration of response		From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years	No