MDACC Study Summary 2005-0668 (Archived)

Study Summary
No. 2005-0668:.......Phase I Studies......Razelle Kurzrock......Phase I Program

Study Summary Title



Study Summary Number:	2005-0668

Study Title:	Phase I Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly x 3, Repeated Every 28 Days, in Subjects with Refractory Brain Metastases

Physician

New Patient Referral



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

Dept:	Phase I Program	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-1226 Contact us about clinical trials

General Information



Disease Group:	Phase I Studies	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Patients will be expected to return weekly while on study and 30 days after last dose.

Treatment Agents:	MPC-6827	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 find the highest tolerable dose of MPC-6827 that can be given to patients with brain cancer. The safety and effectiveness of this drug and how it behaves in the body will also be studied.

Study Objectives / Outcomes

Primary Objectives

To investigate the safety and tolerability of MPC-6827 administered as a 2-hour intravenous (IV) infusion, given once weekly for 3 consecutive weeks, repeated every 28 days in subjects with a wide variety of refractory brain metastases;
To establish the maximum tolerated dose (MTD) of MPC-6827 as a single agent in this subject population;
To characterize the pharmacokinetics (PK) of MPC-6827 administered as a 2-hour IV infusion

Secondary Objectives

To observe for any evidence of antitumor activity of MPC-6827 in treatment of a variety of refractory brain metastases

Study Status Information



Study Activation / Registration Date:	12/12/2005

IRB Review and Approval Date:	11/16/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	40

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

2) Must have refractory cancer metastatic to the brain, with lesion(s) documented by neuroimaging (contrast enhanced CT/MRI) within 28 days prior to study entry, despite prior treatent with current standard of care; including but not limited to radiotherapy. Patients for whom there are no available therapies are eligble.

3) Must have at least one measurable intracranial lesion as defined by the RECIST criteria

4) Age >/= 18

5) Must have ECOG </= 1

6) Must have a predicted life expentancy of >/= 4 weeks

7) Must have adequate hematology and organ function defined by: liver function tests (AST & ALT) </= 3 x ULN; bilirubin </= ULN; neutrophil count >/= 1,500/mm^3; platelets >/= 100,000/mm^3; serum creatinine </= 1.5 x ULN; hemoglobin >/= 9.0 g/dL

8) Must have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery or radiotherapy

9) Must have no baseline peripheral or central neuropathy above Grade 1

Exclusion Criteria:

1) Must NOT have had a prior serious, uncontrolled hypersensitivity reaction to Cremophor EL

2) Must NOT be pregnant or lactating (women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment). Male and female subjects of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the subject must be surgically sterile (with documentation in the subject's medical records). Males must use effective contraception during the study and for at least 3 months following the last dose of MPC-6827.

3) Must NOT receive any other anticancer treatment or investigational therapy within 28 days prior to study Day 1; or within 6 weeks after prior mitomycin C or nitrosourea. Subjects with breast cancer may continue to receive Herceptin maintenance therapy. Subjects with advanced prostate cancer may continue to receive leuteinizing hormone-releasing hormone (LHRH) therapy while on this study.

4) Must NOT have spinal cord compression

5) Must NOT have preexisting dementia/cognitive dysfunction

6) Must NOT require Neupogen or Neulasta to maintain neutrophil count at study entry.

7) Must NOT have primary brain cancer.

8) Must NOT have symptomatic severe arrhythmias or NY Class 3 or 4 heart failures.

9) Have history of ischemic heart disease.

10) Have diabetes.

Links

Registration Number: NCT00393965
Study Information on Clinical Trials Registry (clinicaltrials.gov)