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Recurrent Mantle Cell LymphomaPhase 2NCT00033267

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

A Phase 2 study testing temsirolimus in people with Recurrent Mantle Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Mantle Cell Lymphoma
What is being tested?
temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
Apr 2002to Feb 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 46Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma

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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
temsirolimus
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

Study groups in NCT00033267
Study groupRoleWhat they receive
TreatmentExperimentalPatients 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.
Receives: Drug: temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 weeks

Secondary outcomes (4)

  1. Time to progression

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to the time of progression, assessed up to 5 years

  2. Overall survival

    The distribution of overall survival will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to death due to any cause, assessed up to 5 years

  3. Progression-free survival

    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to progression or death due to any cause, assessed up to 5 years

  4. Duration of response

    Measured: From the date of study registration until the date of progression in the subset of patients who respond, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2002
  3. Primary completionFeb 2006
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033267
Sponsor's protocol ID
NCI-2012-01870
Other IDs
NCI-2012-01870, NCCTG-N0186, CDR0000069269, N0186, N0186, U10CA025224
Status last verified
Dec 2012
First submitted
9 Apr 2002
Last updated
3 Apr 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temsirolimus in people with Recurrent Mantle Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.

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