MDACC Study Summary 2006-0441

Study Summary
No. 2006-0441:.......Lymphoma......Anas Younes......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2006-0441

Study Title:	A MULTI-CENTER, OPEN-LABEL, PHASE II STUDY OF SINGLE-AGENT GX15-070MS ADMINISTERED AS A 24-HOUR INFUSION EVERY 2 WEEKS TO PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN'S LYMPHOMA (HL)

Physician

New Patient Referral



Name:	Anas Younes	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring 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

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients will return every 2 weeks for up to 12 months for treatment. Patients will return 30 days after last treatment. Patients may be asked to return 3 months after last treatment for follow-up testing.

Treatment Agents:	GX15-070MS	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to learn the effectiveness of
GX15-070MS in the treatment of patients with HL. The safety, pharmacokinetics
(PKs), and pharmacodynamics (PDs) of this drug will also be studied.

PKs is the study of how a drug acts in the body over a period of time,
including how it is absorbed into the body's tissues, how it moves throughout
the body, and how the body gets rid of it. PDs is the study of the effect of a
drug on a tumor.

Study Objectives / Outcomes

Primary Objectives:

Determine the success rate (complete response/remission [CR], partial response/remission [PR], and stable disease [SD]) to GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.

Characterize the safety profile of GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.

Determine the steady state pharmacokinetic (PK) parameters of GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.

Determine the pharmacodynamic (PD) response to GX15-070MS administered as a 24-hour infusion every 2 weeks at a dose of 60 mg.

Study Status Information



Study Activation / Registration Date:	08/04/2006

IRB Review and Approval Date:	06/21/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	Up to 29

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) Patients must have pathological confirmation of Hodgkin's Lymphoma (nodular sclerosis, mixed cellularity, or lymphocyte-rich classical HL).

2) Patients must have measurable disease using the Cheson criteria with at least one lesion >/= 2.0 cm using conventional technique or >/= 1.0 cm with spiral CT scan in a single dimension.

3) Patients must have evidence of progressive disease following at least one prior line of combination chemotherapy. Patients must have failed, refused, or otherwise not be a candidate for a stem cell transplant.

4) Patient's last dose of chemo-, immuno-, biological, or investigational therapy must be >/= 14 days prior to administration of GX15-070MS. Acute toxicities from prior therapy must have resolved to </= Grade 1.

5) Patients must be >/= 18 years of age.

6) Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

7) Patients must have normal organ function as defined below: a) Total bilirubin: </= 2 mg/dL unless resulting from hemolysis; b) AST(SGOT)/ALT(SGPT): </= 2.5 x institutional upper limit of normal; c) Creatinine: within normal institutional limits OR d) Calculated creatinine clearance: >/= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal; e) Baseline hematological parameters: no restrictions.

8) Women of child-bearing potential must have a negative urine or serum pregnancy test result prior to study entry. In addition, because of the potential for unknown risks to an unborn child that could result from exposure to GX15-070MS, women of child-bearing potential and men with partners of child-bearing potential must agree to abstain from sexual activity that would result in pregnancy for the duration of study participation.

9) Patients must be willing to submit to blood sampling for the planned PK and PD analyses.

10) Patients must have the ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria:

1) Patients receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy. In addition, patients who have had prior exposure to GX15-070MS are also excluded from this study.

2) Patients with a history of allergic reactions attributed to components of the formulated product.

3) Patients with a history of seizure disorders or central nervous system (CNS)/leptomeningeal lymphoma.

4) Patients with a baseline QTc > 460 msec.

5) Patients with prior allogeneic stem cell transplant if there is evidence of graft versus host disease, or requirement for steroids or other immunosuppressive therapy.

6) Patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements.

7) Pregnant women and women who are breast feeding.

Links

Registration Number: NCT00359892
Study Information on Clinical Trials Registry (clinicaltrials.gov)