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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Recurrent Mantle Cell Lymphoma

Treatments

Drug: temsirolimus

Study type

Interventional

Funder types

NIH

Identifiers

NCT00033267

NCI-2012-01870 (Registry Identifier)

CDR0000069269

N0186 (Other Identifier)

NCCTG-N0186

U10CA025224 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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