MDACC Study Summary 2007-0595

Study Summary
No. 2007-0595:.......Advanced Cancers......Aung Naing......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2007-0595

Study Title:	PHASE I STUDY OF IMC-A12 (NSC# 742460) IN COMBINATION WITH TEMSIROLIMUS CCI-779 (NSC# 683864) IN PATIENTS WITH ADVANCED CANCERS.

Physician

New Patient Referral



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

Dept:	Investigational Cancer Therapeutics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-0181 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	NCI/CTEP

Phase of Study:	Phase I	Return Visit:	This study includes a maximum of 12 scheduled visits over 8 weeks per patient starting from Screening through the completion of 2 cycles.

Treatment Agents:	IMC-A12 Temsirolimus (CCI-779)	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 find the highest tolerable dose
combination of IMC-A12 and temsirolimus that can be given to patients with
advanced or metastatic cancer. Researchers will look at safety of the study
drugs, and whether the study dosing schedule is tolerated by participants.
Researchers will also perform biomarker tests to study how IMC-A12 and
temsirolimus affect genes (material in the cells passed from parent to child
that gives the child certain traits or characteristics) or proteins (the
building blocks of cells) found in the blood.

Study Objectives / Outcomes

Primary Objectives

To evaluate the safety and tolerability; and to determine maximum tolerated dose (MTD) of the combination of IMC-A12 with temsirolimus in patients with or without biopsiable advanced cancers.
To evaluate the biologic effect of each individual drug and this drug combination on expression/phosphorylation of potential markers of response in patients with biopsiable disease.
To assess tumor metabolism by Positron Emission Tomography (PET).

Secondary Objectives

To report the clinical tumor response of this combination in a descriptive fashion.

Study Status Information



Study Activation / Registration Date:	05/07/2008

IRB Review and Approval Date:	04/04/2008

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	99

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 with advanced or metastatic cancer.

2) Patients enrolled in the expansion cohorts may be on antidiabetic treatment, but baseline glucose should be </= 120

3) All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must also have signed an authorization for the release of their protected health information.

4) Patients are allowed to have unlimited prior treatments.

5) Patients must be registered in the MDACC institutional database (CORE) prior to treatment with study drug.

6) Estimated life expectancy of greater than 3 months.

7) Patients must be >/= 4 weeks beyond treatment of any chemotherapy, other investigational therapy, biological, targeted agents or radiotherapy, and must have recovered to </= grade 1 toxicity or previous baseline for each toxicity. Exceptions: Patients must be >/= 6 weeks beyond treatment with monoclonal antibodies; patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field.

8) Patients must be >/= 2 weeks beyond treatment of hormonal therapy.

9) ECOG performance status </= 1.

10) Abnormal organ function is permitted. However, patients must have absolute neutrophil count >/= 1500/mL; platelets >/= 100,000/mL; creatinine </= 2X ULN; T. Bilirubin </= 1.5 X ULN; AST(SGOT) and/or ALT(SGPT) </= 5X ULN.

11) Women of childbearing potential MUST have a negative serum or urine HCG test unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity). Patients should not become pregnant or breastfeed while on this study. Sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 3 months after the last dose.

12) Patients must be >/= 16 years of age. Patients with Ewings Sarcoma must be >/= 14 years of age.

Exclusion Criteria:

1) Patients may not be receiving any other investigational agents

2) Patients who are pregnant or breastfeeding.

3) Patients with history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.

4) Patients with uncontrolled intercurrent illness including, but not limited to, active infection requiring hospitalization.

5) Patients with history of hypersensitivity to monoclonal antibody treatment or immunosuppressant agents.

6) Patients with history of CVA, myocardial infarction or unstable angina within the previous six months before starting therapy.

7) Patients with New York Heart Association Class III or greater congestive heart failure or uncontrolled hyperlipidemia (cholesterol > 300 mg/dl; triglyceride 2.5X ULN despite lipid lowering agent).

8) Patients with fasting blood sugar >120. Patients who are on oral hypoglycemic agents and insulin will be excluded. Exception: patients in the expansion cohorts may be on antidiabetic treatment (including hypoglycemic agents and/or insulin) if controlled.

9) Patients on drugs that are strong P450 CYP3A4 inhibitors or inducers. These drugs should be stopped 5 half-lives prior to starting investigational agents with temsirolimus. The strong inducing or inhibiting agents should not restart until 1 week after the end of study treatment. The PI or his designee will go over/check the list of medication for individual patients. NOTE: We will allow physiologic replacement of steroids (with either prednisone or hydrocortisone) in patients with adrenalectomy.

10) Patients with history of brain metastasis are eligible, however the brain metastases should have been treated (treatment defined as surgery or RT) and the patient should have been free from symptoms/signs and off steroids for at least 3 months before study entry.

11) Patients with highly aggressive lymphoma (i.e. Burkitt's)

Links

Registration Number: NCT00678769
Study Information on Clinical Trials Registry (clinicaltrials.gov)