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CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00086840
Enrollment
60
Registered
2004-07-12
Start date
2004-05-31
Completion date
Unknown
Last updated
2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia

Brief summary

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

Detailed description

OBJECTIVES: I. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed chronic lymphocytic leukemia. OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic lymphocytic leukemia \[CLL\] vs transformed CLL). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.

Interventions

DRUGtemsirolimus

Given IV

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of chronic lymphocytic leukemia (CLL) * Relapsed, refractory, or transformed disease * Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression * Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody * Transformed CLL (Richters transformation), must meet both of the following criteria: * Histologically confirmed lymphoma * Measurable disease * No CNS disease * Performance status - ECOG 0-2 * Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease) * SGOT and SGPT \< 3 times upper limit of normal * Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present * No history of 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 concurrent uncontrolled illness * See Disease Characteristics * No concurrent prophylactic hematopoietic colony-stimulating factors * See Disease Characteristics * More than 2 weeks since prior cytotoxic chemotherapy and recovered * More than 2 weeks since prior radiotherapy and recovered * No other concurrent investigational or antitumor agents * No other concurrent cytotoxic agents * No concurrent combination antiretroviral therapy for HIV-positive patients

Design outcomes

Primary

MeasureTime frameDescription
Response (CR or PR)6 monthsDefined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026