Clinical trial NCT00086840: CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official title: A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response (CR or PR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Francis Giles
role: PRINCIPAL_INVESTIGATOR
References: