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

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

Study Overview

• Status: Terminated
• Conditions: Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia
• Intervention / Treatment: Other: laboratory biomarker analysis; Drug: temsirolimus

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (temsirolimus); 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.	Other: laboratory biomarker analysis; Correlative studies; Drug: temsirolimus; Given IV; Other Names: Torisel; CCI-779; cell cycle inhibitor 779

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: July 8, 2004
• First Submitted That Met QC Criteria: July 9, 2004
• First Posted (Estimate): July 12, 2004

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Disease Attributes; Leukemia, B-Cell; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Leukemia; Hodgkin Disease; Recurrence; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: NCI-2012-02598; N01CM17003 (U.S. NIH Grant/Contract); MDA-2003-0886; CDR0000371619 (Registry Identifier: PDQ (Physician Data Query))