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

Phase 2

Terminated

• Conditions: Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia
• Interventions: Drug: temsirolimus; Other: laboratory biomarker analysis

• Registration Number: NCT00086840
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-07-08
• Study First Submitted QC: 2004-07-09
• Study First Posted: 2004-07-12
• Primary Completion: 2005-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (temsirolimus)	laboratory biomarker analysis	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.
Treatment (temsirolimus)	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.

Primary Outcome Measures

Name	Time	Method
Response (CR or PR)	6 months	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).

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States