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

Refractory Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00086840
• Other study ID #: NCI-2012-02598
• Secondary ID: MDA-2003-0886N01
• Status: Terminated
• Phase: Phase 2
• First received: July 8, 2004
• Last updated: January 23, 2013
• Start date: May 2004

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Adult Hodgkin Lymphoma
• Refractory Chronic Lymphocytic Leukemia

Intervention

Drug:
• temsirolimus
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response (CR or PR)	Defined 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).	6 months	No