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Study Summary
No. 2004-0612:.......Lymphoma......Barbara Pro......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:		2004-0612
Study Title:A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
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Physician New Patient Referral
Name:Barbara ProPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		weekly
Treatment
Agents:		CCI-779Home Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		NA
Description/
Intervention:		The goal of this clinical research study is to learn if CCI-779 can shrink or
slow the growth of B-cell lymphoma or chronic lymphocytic leukemia (CLL). The
safety of CCI-779 will also be studied.
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Study Objectives / Outcomes
Primary Objectives:
To determine the complete and partial response rate to CCI-779 in patients with recurrent or refractory B-cell lymphoma and CLL.

Secondary Objectives:
1. To determine the toxicity and safety of CCI-779 in patients with recurrent or refractory B-cell lymphoma and CLL.
2. To determine the relationship between the degree of activation of P13/AKT/mTOR pathway, levels of CDK inhibitors in lymphoma and response to CCI -779.
3. To determine the relationship between CCI-779 induced inactivation of mTOR and response.

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Study Status Information
Study Activation / Registration Date:05/31/2005
IRB Review and Approval Date:09/15/2004
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:101
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Histologically or cytologically confirmed recurrent or refractory B-cell lymphoma. Patients will be stratified into 3 categories: 1) aggressive B-cell lymphoma (diffuse large B-cell lymphoma and transformed lymphoma), 2) Follicular lymphoma, 3) Small lymphocytic lymphoma (including CLL and other B-cell small lymphocytic disorders, but excluding mantle cell lymphoma).

2) Measurable disease - defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as >/= 20mm w/ conventional techniques or as >/= 10mm w/ spiral CT scan. For CLL & Waldenstrom's only bone marrow involvement or peripheral blood involvement are required.

3) All Patients will have relapsed or refractory disease. Maximum number of prior therapies: Group A: (1) Patients with refractory disease (i.e. less than a partial response ot the last treatment regimen before enrollment) will have received a maximum of 3 prior treatments regimens. (2) Patients with sensitive disease (i.e. at least a partial response to the last treatment regimen before enrollment) will have received maximun of 4 prior regimens. Group B and Group C: Patients will not have received more than 5 lines of prior therapy.

4) Age >/= 18 years

5) Life expectancy > 3 months

6) ECOG performance status </= 2

7) Normal organ and acceptable marrow function: (1) ANC >/= 1,000/microL; (2) PLT >/= 50,000/microL*; (3) Bilirubin l</= 1.5 institutional ULN**; (4) AST/ALT </= 2.5 X ULN; (5) creatinine </= 1.5 ULN; (6) fasting serum cholesterol </= 350 mg/dL; (7) fasting triglycerides </= 400mg/dL (* patinets with thrombocytopenia due to bone marrow involvement must has platelets > 20,000/microL. NOTE: Patients with elevated unconjugated bilirubin due to Gilbert's disease will be eligible.)

8) Must agree to use adequate contraception prior to study entry and for the duration of participation

9) Ability to understand and willingness to sign a written informed consent document

10) Presence of peripheral lymph node involvement, bone marrow involvement or blood involvement is required. In the case of bone marrow involvement, there should be at least 10% bone marrow involvement as evaluated by an appropriate core biopsy.

11) Patients will have exhausted all potentially curative treatment options because of lack of response, relapse, or ineligibility.

12) Caveats: (1) Patients who have failed autologous transplant are eligible. The salvage regimen given before autologous transplantation, the conditioning regimen and any maintenance given after transplantation will be counted as one treatment regimen. (2) Prior treatment with rituximab or campath will not be considered prior therapy as these treatments are often repeatedly administered and are devoid of serious myelosuppressive effects. (3) There is no limitation to the amount of prior radiotherapy received.
Exclusion Criteria:1) Patients with mantle cell lymphoma

2) Chemotherapy or radiation therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier

3) Patients may not be receiving other investigatonal agents

4) Patients with known CNS involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

5) History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779

6) No unconventional therapies, food, or vitamin supplements containing St. John's Wort are allowed. (St. John's Wort is a known inducer of the CYP3A4 and therefore potentially interfering with the metabolism of CCI-779).

7) Patients with currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.

8) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

9) Pregnant women are excluded from this study because CCI-779 is an inhibitor of mRNA translation with the potential for teratogenci or abortifacient effects. Because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with CCI-779, breast feeding should be discouraged if the mother is treated with CCI-779.

10) HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with CCI-779. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
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Links
Registration Number: NCT00290472
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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