Full Text View
Tabular View
No Study Results Posted
Related Studies
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00033267   Information provided by National Cancer Institute (NCI)
First Received: April 9, 2002   Last Updated: July 23, 2008   History of Changes

April 9, 2002
July 23, 2008
April 2002
February 2008   (final data collection date for primary outcome measure)
Overall response (complete and partial) during first 24 weeks of treatment [ Designated as safety issue: No ]
Overall response (complete and partial) during first 24 weeks of treatment
Complete list of historical versions of study NCT00033267 on ClinicalTrials.gov Archive Site
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to progression
  • Overall survival
  • Progression-free survival
  • Duration of response
 
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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the objective responses in patients with previously treated mantle cell non-Hodgkin's lymphoma treated with CCI-779.
  • Determine the toxic effects of this drug in these patients.
  • 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.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study within 2 years.

Phase II
Interventional
Treatment, Open Label
Lymphoma
Drug: temsirolimus
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
February 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8 g/dL

Hepatic:

  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin ≤ 1.5 times ULN
  • AST ≤ 3 times ULN (5 times ULN if liver metastases are present)

Renal:

  • Creatinine ≤ 2 times ULN

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 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

Chemotherapy:

  • 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

Endocrine therapy:

  • Concurrent corticosteroids for adrenal insufficiency allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy for MCL

Surgery:

  • Not specified

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033267
 
CDR0000069269, NCCTG-N0186
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Stephen M. Ansell, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP