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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033267
First received: April 9, 2002
Last updated: April 2, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Recurrent Mantle Cell Lymphoma
Drug: temsirolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to progression [ Time Frame: Time from registration to the time of progression, assessed up to 5 years ] [ Designated as safety issue: No ]
    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

  • Overall survival [ Time Frame: Time from registration to death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    The distribution of overall survival will be estimated using the method of Kaplan-Meier.

  • Progression-free survival [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2002
Study Completion Date: February 2008
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033267

Locations
United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Ansell North Central Cancer Treatment Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033267     History of Changes
Other Study ID Numbers: NCI-2012-01870, NCI-2012-01870, NCCTG-N0186, CDR0000069269, N0186, N0186, U10CA025224
Study First Received: April 9, 2002
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014