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Study Summary
No. 2008-0145:.......Lymphoma; Skin......Madeleine Duvic......Dermatology
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Study Summary Title
Study Summary
Number:
2008-0145
Study Title:Study H6Q-MC-JCCB
A Phase 2, Open-Label, Multicenter Study of Single-
Agent Enzastaurin in Patients with Relapsed Cutaneous
T-Cell Lymphoma
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Physician New Patient Referral
Name:Madeleine DuvicPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:DermatologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-4578
Contact us about clinical trials
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General Information
Disease Group:Lymphoma
Skin
Supported By:Eli Lilly
Phase of Study:Phase IIReturn
Visit:
every 4 weeks
Treatment
Agents:
EnzastaurinHome Care:n/a
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to learn if enzastaurin can help to
control relapsed CTCL. The safety of this drug will also be studied.
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Study Objectives / Outcomes
Primary:
The primary objective of this Phase 2 study is to determine the overall objective tumor
response rate of enzastaurin in patients with relapsed CTCL.

Secondary: The secondary objectives of the study are to assess:
  • Duration of response for responding patients
  • Time to progression
  • Time to objective response for responding patients
  • Patient-reported measures of health-state utility and pruritus
  • Biomarkers relevant to the effects of enzastaurin on various markers of malignant
  • T-lymphocytes in skin biopsies and peripheral blood samples
  • Safety and tolerability of enzastaurin in this patient population
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Study Status Information
Study Activation / Registration Date:10/23/2008
IRB Review and Approval Date:08/06/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:80
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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) >/= 18 years of age

2) Histologically confirmed mycosis fungoides (MF) or Sezary Syndrome (SS)

3) Stage IB to IVB disease at screening (TNMB classification)

4) Recurrent or refractory disease after at least 1 prior therapy, 1 of which must be either bexarotene or vorinostat. Patients who are intolerant to both medications are also eligible.

5) A baseline ECOG performance status of 0, 1, or 2

6) Have adequate organ function defined as: Hepatic: total bilirubin </= 1.5 x upper limit of normal (ULN); alanine transaminase/aspartate transaminase (ALT/AST) </= 2.5 x ULN; Renal: serum creatinine </= 1.5 x ULN; Adequate bone marrow reserve: platelets >/= 75 x 10^9 /L; absolute neutrophil count (ANC) >/= 1.0 x 10^9 /L

7) At least 30 days must have passed since prior local, systemic, or radiation treatment for CTCL. Patient must have recovered from the toxic effects of prior therapies

8) Expected survival of > 12 weeks

9) Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (intrauterine device, birth control pills, or barrier device), during and for 3 months after discontinuation of study treatment.

10) Women with childbearing potential must have negative serum pregnancy test </= 3 days prior to study enrollment

11) Must sign an informed consent document (or legal representative has given informed consent)

12) Exhibit patient compliance and geographic proximity that allow for adequate follow-up

Exclusion Criteria:1) Receiving concurrent administration of any other systemic or localized anticancer therapy (including radiation, PUVA, and photopheresis)

2) Unable to swallow tablets

3) Receiving high potency oral or topical steroids. Low potency oral steroid equivalent to or less than 10 mg prednisone (or equivalent) per day or low- to mid-potency topical steroids may be permitted in patients who have been on a stable dose for at least 4 weeks prior to screening. Oral or topical antihistamine is allowed.

4) Unable to discontinue use of carbamazepine, phenobarbital, or phenytoin

5) Prior treatment with enzastaurin

6) Have a serious concomitant systemic disorder that could preclude the patient from benefiting or completing the study based on the discretion of the investigator

7) Patients must be disease free of prior malignancies for >/= 2 years with exception of currently treated squamous cell and basal cell carcinoma of the skin, melanoma in situ with histologically confirmed free margins, or carcinoma in situ of the cervix.

8) Have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the New York Heart Association (NYHA) Class III or IV

9) Have ECG abnormalities, including baseline 12-lead ECG with QTc interval of > 430 msec in males or > 450 msec in females, or QRS duration of > 100 msec

10) Known to be HIV positive.

11) Are pregnant or breastfeeding

12) Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

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Links
Registration Number: NCT00744991
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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