A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
18 Years
N/A
Both
Recurrent Mantle Cell Lymphoma
Trial Information
A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
Outcome Description:
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.
Outcome Time Frame:
Up to 24 weeks
Safety Issue:
No
Principal Investigator
Stephen Ansell
Investigator Role:
Principal Investigator
Investigator Affiliation:
North Central Cancer Treatment Group
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-01870
NCT ID:
NCT00033267
Start Date:
April 2002
Completion Date:
Related Keywords:
- Recurrent Mantle Cell Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell
Name | Location |
|---|---|
| North Central Cancer Treatment Group | Rochester, Minnesota 55905 |
