Skip to content
Triangle logo TriangleGet started
← Study library

NCT00290472 · REGISTRY CONDITION SEARCH

CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2014-05-23

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Objective Overall Response Rate

→

outcome · POSTED

Duration of Response

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including the following subtypes: * Aggressive B-cell lymphoma (Group A) * Diffuse large B-cell lymphoma * Transformed lymphoma * Follicular lymphoma (Group B) * Small lymphocytic lymphoma * Chronic lymphocytic leukemia (CLL) (Group C) * Other B-cell small lymphocytic disorders * No mantle cell lymphoma * No potentially curative treatment options because of lack of response, relapse, or ineligibility * Relapsed or refractory disease * Patients with refractory disease (i.e., less than a partial response to the last treatment) must have received no more than 3 prior regimens (group A) * Patients with sensitive disease (i.e., at least a partial response to the last treatment) must have received no more than 4 prior regimens (group A) * Patients who have failed prior autologous transplantation are eligible (group A) * No more than 5 prior regimens (groups B and C) * The salvage regimen, conditioning regimen, and any maintenance therapy are considered 1 regimen * Prior rituximab or alemtuzumab is not considered prior therapy * No limitation to the amount of prior radiotherapy * No CNS involvement * Performance status: ECOG 0-2 OR Karnofsky 60-100% * Life expectancy more than 3 months * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No prior allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779 * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix Completed therapy and considered \< 30% risk of relapse * No other concurrent uncontrolled illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent prophylactic hematopoietic colony-stimulating factors * No concurrent pegfilgrastim * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * More than 4 weeks since prior radiotherapy and recovered * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum (St. John's wort) * No other concurrent known inducers of CYP3A4 * No other concurrent investigational agents * No other concurrent anticancer therapy * Measurable disease\* * At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan \[Note: \*Only bone marrow or peripheral blood involvement required for CLL and Waldenstrom's macroglobulinemia \] * Absolute neutrophil count \>= 1,000/mm3 * Bilirubin =\< 1.5 times upper limit of normal (ULN) * AST and ALT =\< 2.5 times ULN * Creatinine =\< 1.5 times ULN * Fasting cholesterol =\< 350 mg/dL * Fasting triglycerides =\< 400 mg/dL * Platelet count \>= 50, 000/mm3 (\> 20,000/mm3 for patients with thrombocytopenia due to bone marrow involvement)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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 are followed every 8 weeks.
    intervention Names
    1. Drug: temsirolimus
    label
    Arm I
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    name
    temsirolimus
    other Names
    1. CCI-779
    2. cell cycle inhibitor 779
    3. Torisel
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
89
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
    measure
    Objective Overall Response Rate
    time Frame
    Up to 6 years
  2. description
    Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
    measure
    Duration of Response
    time Frame
    Up to 6 years
  3. description
    The overall survival was evaluated using the Kaplan-Meier estimator.
    measure
    Overall Survival
    time Frame
    Up to 6 years
Full study description
brief Summary
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
detailed Description
PRIMARY OBJECTIVES: I. Determine the complete and partial response rate in patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779. II. Determine the toxicity and safety of this drug in these patients. III. Correlate the degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in patients treated with this drug. IV. Correlate CCI-779 induced inactivation of mTOR with response in these patients. OUTLINE: Patients are stratified according to disease (aggressive lymphoma \[group A\] vs follicular lymphoma \[group B\] vs small lymphocytic lymphoma or chronic lymphocytic leukemia \[group C\]). 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 are followed every 8 weeks.
Source references
references
  1. citation
    Smith SM, van Besien K, Karrison T, Dancey J, McLaughlin P, Younes A, Smith S, Stiff P, Lester E, Modi S, Doyle LA, Vokes EE, Pro B. Temsirolimus has activity in non-mantle cell non-Hodgkin's lymphoma subtypes: The University of Chicago phase II consortium. J Clin Oncol. 2010 Nov 1;28(31):4740-6. doi: 10.1200/JCO.2010.29.2813. Epub 2010 Sep 13.
    pmid
    20837940
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-eb5ce562e7c9d300477d
      requested nct id
      NCT00290472
      primary nct id
      NCT00290472
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      8ebc733e4a368f5979c4b9aa5b2e99a02eff707592684493c2d30b0ac2488cda
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-eb5ce562e7c9d300477d
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00290472
      occurrences
      1. context exact
        NCT00290472
        end
        11
        exact text
        NCT00290472
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/976/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      b8f51426ffd70078b299c79df6a7d1ccccc79be7244be704c537e79b79f820f6

    Preserved source evidence · Not medical advice