- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033267
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- North Central Cancer Treatment Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
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.
|
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: Up to 24 weeks
|
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.
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Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: Time from registration to progression or death due to any cause, assessed up to 5 years
|
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
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Time from registration to progression or death due to any cause, assessed up to 5 years
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Time to progression
Time Frame: Time from registration to the time of progression, assessed up to 5 years
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The distribution of time to progression will be estimated using the method of Kaplan-Meier.
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Time from registration to the time of progression, assessed up to 5 years
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Overall survival
Time Frame: Time from registration to death due to any cause, assessed up to 5 years
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The distribution of overall survival will be estimated using the method of Kaplan-Meier.
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Time from registration to death due to any cause, assessed up to 5 years
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Duration of response
Time Frame: From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years
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From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Ansell, North Central Cancer Treatment Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- NCI-2012-01870 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA025224 (U.S. NIH Grant/Contract)
- NCCTG-N0186
- CDR0000069269
- N0186 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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