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

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 2

Conditions: Recurrent Adult Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Recurrent Adult Diffuse Large Cell Lymphoma

Treatments: Other: laboratory biomarker analysis; Drug: temsirolimus

Study type: Interventional

Funder types: NIH

Identifiers

NCT00086840

NCI-2012-02598

N01CM17003 (U.S. NIH Grant/Contract)

CDR0000371619 (Registry Identifier)

MDA-2003-0886

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Treatment (temsirolimus)

Experimental group

Description:

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:

Other: laboratory biomarker analysis

Drug: temsirolimus