MDACC Study Summary 2005-0806 (Archived)

Study Summary
No. 2005-0806:.......Advanced Cancers; Solid Tumors......Razelle Kurzrock......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2005-0806

Study Title:	Multiple Ascending Dose (MAD) Phase I Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion on QW and Q3W Schedules in Patients with Advanced Solid Tumors, Non-Hodgkin's Lymphomas or Hodgkin's Lymphoma

Physician

New Patient Referral



Name:	Razelle Kurzrock	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:	713-794-1226 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Solid Tumors	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	qW 24, 48 and 72 hrs after initial infusion on Weeks 1 and 7; then weekly q3W 24, 48 and 72 hrs after infusion on C1/D1, 8 and 15; C2/D1; C3/D8; C4/D1; then weekly Both Final visit and 30 days following final dose.

Treatment Agents:	R1507	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 R1507 (also known as RO4858696) that can be given to patients with advanced
or metastatic cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma, or
soft-tissue or bone sarcoma. The way that R1507 is absorbed into your blood
stream and then moved through your body will be studied. The safety and
effectiveness of R1507 will also be studied.

Study Objectives / Outcomes

Primary Objective:
The primary objective of the trial is to describe the pharmacokinetics (PK), to determine the maximally tolerated dose (if achieved), and to assess the effect of R1507 on tumor expression of IGF-1R in patients with advanced solid neoplasms and non-Hodgkin's lymphoma.

Additional co-primary objective: To compare pharmacokinetics of R1507 manufactured in CHO cell lines with the pharmacokinetics of R1507 manufactured in SP2/0 cell lines.

Secondary Objectives:

Describe the tolerability and adverse event profile of R1507
Describe the pharmacodynamics of R1507
Describe any oncologic responses and the durations of any responses to R1507
Determine the appropriate Phase II dose of R1507

Study Status Information



Study Activation / Registration Date:	05/26/2006

IRB Review and Approval Date:	02/01/2006

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	up to 96 patients

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 a histologically or cytologically confirmed solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma. For enrollment in the extended patient group at dose level 3 of the qW cohort, a diagnosis of malignant soft-tissue or bone sarcoma (including extra-cranial primitive neuroectodermal tumor - PNET) is required.

2) Patients must have a malignancy that has not responded to an adequate course of available therapy, that has progressed or recurred despite an adequate course of available therapy, that is not curable by available therapy or for which no accepted standard therapy exists.

3) Age >/= 17 years

4) ECOG Performance Score of 0 or 1

5) Adequate bone marrow as evidenced by: (1) ANC >/= 1,500/microliters; (2)platelet count >/= 100,000/microliters

6) CD4 count of >/= 200/microliters

7) Adequate renal function as evidenced by serum creatinine </= 2.0 mg/dL

8) Adequate hepatic function as evidenced by: (1) serum total bilirubin </= 2.0 mg/dL; (2) SGOT/SGPT </= 3 x ULN for the reference lab (</= 5 x ULN for patients with known hepatic metastases)

9) Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy

10) Patients with CNS metastases are eligible for enrollment if they have received prior radiotherapy to site(s) of CNS metastatic disease, have been off glucocorticoids for at least 4 weeks and have no overt evidence of neurological deficit

11) Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial

12) Women of childbearning potential as well as fertile men and their partners must agree to use an effective form of contraception duirng the study and for 120 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

1) Patients with an active infection or with a fever >/= 38.5 degrees (centigrade) within 3 days of the first scheduled day of dosing

2) Patients who require treatment with chronic pharmacologic doses of glucocorticoids, or who require, or who have taken within the last 6 months, any of the following immunosuppressive agents: interferon-alpha, interferon-beta, interleukin-2, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab

3) Patients with known hypersensitivity to any of the components of R1507 or who have had prior hypersensitivity reactions to monoclonal antibodies

4) Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives or longer (up to 28 days) as deemed clinically indicated of the investigational therapy in question prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)

5) Patients with diabetes mellitus, defined as casual, serum glucose concentration of >/= 200 mg/dL, fasting serum glucose of >/= 126 mg/dL, 2-hour postload serum glucose concentration of >/= 200 mg/dL following an oral glucose tolerance test, or the need for an oral hypoglycemic agent or insulin in order to keep the serum glucose below the above levels.

6) Severe uncontroled systemic disease (e.g. hypertention, clniically significant cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture).

7) NYHA Class III or IV congestive heart failure

8) Patients with positive pregnancy tests or who are known to be pregnant or lactating

9) Patients with reproductive potential not willing to use effective method of contraception.

10) Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likley to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

11) History of allogeneic transplant, including bone marrow transplant

12) Known HIV or Hepatitis B or C (active, previously treated, or both)

Links

Registration Number: NCT00400361
Study Information on Clinical Trials Registry (clinicaltrials.gov)