MDACC Study Summary 2007-0445

Study Summary
No. 2007-0445:.......Melanoma......Wen-Jen Hwu......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2007-0445

Study Title:	Dose Finding Phase I Study of the Treatment of Metastatic Melanoma with MPC-6827 in Combination with Temozolomide

Physician

New Patient Referral



Name:	Wen-Jen Hwu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Melanoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2921 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	Myriad Pharmaceuticals, Inc

Phase of Study:	Phase I	Return Visit:	In each 8-week treatment cycle: patients will come to MDACC weekly x6 for MPC-6827 IV infusion.

Treatment Agents:	MPC-6827	Home 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 the highest safe dose of the investigational drug MPC-6827 that can be given in combination with temozolomide in patients with metastatic melanoma. Also, new study procedures have been added to monitor your safety if certain laboratory results are abnormal.

Study Objectives / Outcomes

The primary objective is to define the safety and tolerability (maximum tolerated dose) of MPC-6827 when administered in
combination with temozolomide in subjects with metastatic melanoma. metastatic to the brain.

The secondary objectives are:

To characterize the pharmacokinetics (PK) of MPC-6827 (given by

intravenous injection) and temozolomide (given orally) when administered
in combination.

To observe for any evidence of anti-tumor activity of the combination

therapy in treatment of melanoma metastatic to the brain.

Study Status Information



Study Activation / Registration Date:	02/21/2008

IRB Review and Approval Date:	01/11/2008

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	up to 36

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) Have histologically proven melanoma.

2) Troponin-I elevated above the normal range

3) For subjects with brain metastases that require radiation, (i.e., whole brain radiotherapy or sterotactic), therapy must have been completed at least 4 weeks prior to Day 1 of Study Drug.

4) Have unresectable melanoma with measurable metastases.

5) Be capable of understanding the informed consent (ICF) and complying with the protocol, and must sign the ICF prior to the performance of any study-related procedures.

6) Be a minimum of 4 weeks since prior surgical resection or major surgical procedure prior to Day 1 of Study Drug.

7) Be a minimum of 2 weeks since chemotherapy or biochemotherapy prior to Day 1 of Study Drug Major Exclusion Criteria.

8) Be age 18 or older.

9) Have a performance score of Karnosfsky greater than or equal to 60%, or Eastern CooperativeOncology Group (ECOG) less than or equal to 2, or WHO less than or equal to 2

10) If steroids are needed, be on a stable or decreasing dose for at least 1 week.

11) Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy to CTC grade less than or equal to 1.

12) Have the following laboratory parameters: a. Hemoglobin greater than or equal to 9.0 gm/dL, b. Platelet count greater than or equal to 100,000/mm3, c. Absolute Neutrophil Count greater than or equal to 1,500/mm3, d. INR less than or equal to 1.2, e. Creatinine (Cr) less than or equal to 1.5 mg/dL, f. Liver function tests less than or equal to 2.5 X ULN, g. Lactate dehydrogenase (LDH) less or equal to 1.5 x ULN

13) If female and of childbearing potential, the subject must use appropriate birth control (abstinence, barrier methods, oral contraceptives, and/or intrauterine devices) during the entire duration of the study, or the female subject must be surgically sterile (with documentation in the subject's medical records) during the entire duration of the study and for at least 3 months following last dose of MPC-6827

14) Male subjects must use effective contraception (vasectomy or barrier methods, or surgical sterilization or post-menopausal status of partner) during the study and for at least 3 months following the last dose of MPC-6827.

Exclusion Criteria:

1) Have had a prior serious, uncontrolled hypersensitivity reaction to Cremophor� EL.

2) Have ocular melanoma.

3) Have primary intradural melanoma or leptomeningeal involvement.

4) Are pregnant or lactating (women of childbearing potential must have a negative urine pregnancy test within 7 days prior to Day 1 of Study Drug.

5) Have documented current/active intra-tumor hemorrhage within 3 weeks prior to Day 1 of Study Drug confirmed by CT/MRI. (Minimal radiographic findings, consistent with hemorrhage, are allowed in the absence of clinical findings.)

6) Require anticoagulation including cardioprotective aspirin. Subjects who choose to stop taking cardioprotective aspirin will have a 3-day washout prior to Day 1 of Study Drug.

7) Have a cardiac ejection fraction less than 50% by MUGA or ECHO.

8) Require granulocyte colony stimulating factor (G-CSF) to maintain neutrophil count at study entry (Day 1 of Study Drug).

9) Have cardiovascular disease (history of unstable angina or myocardial infarction). Subjects 45 years old or greater with significant cardiovascular risk factors (eg, poorly controlled diabetes as evidenced by retinal neovascularization, exertional chest pain uncontrolled hypercholesterolemia, active smoker (chronic tobacco use within 1 year of Day 1 of Study Drug) ) must undergo a stress thallium scan and, if positive, are excluded.

10) Have cerebrovascular disease (history of stroke and/or transient ischemic attacks).

11) Have troponin-I elevated above the normal range

12) Have uncontrolled hypertension (systolic blood pressure greater than 140 mm Hg; or diastolic blood pressure greater than 90 mm Hg) over 1 week observation.

13) Have used any investigational therapy within 28 days prior to Day 1 of Study Drug .

14) Cannot be appropriately imaged by either MRI or contrast-enhanced CT.

Links

Registration Number: NCT00609011
Study Information on Clinical Trials Registry (clinicaltrials.gov)