Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01870 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCCTG-N0186 | |||
| CDR0000069269 | |||
| N0186 | Other Identifier | North Central Cancer Treatment Group | |
| N0186 | Other Identifier | CTEP | |
| U10CA025224 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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 CR receive 2 additional courses beyond CR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temsirolimus | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Overall survival |
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Ansell | North Central Cancer Treatment Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Cancer Treatment Group | Rochester | Minnesota | 55905 | United States |
Not provided
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C401859 | temsirolimus |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| 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 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |