MDACC Study Summary 2006-0378

Study Summary
No. 2006-0378:.......Melanoma......Patrick Hwu......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2006-0378

Study Title:	A Phase I/II Study of CR011-vcMMAE in Subjects with Unresectable Stage III or Stage IV Melanoma

Physician

New Patient Referral



Name:	Patrick 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:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	2 Times Per Month

Treatment Agents:	CR011-CLN-11	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 dose of CR011-vcMMAE that can be safely given to people with advanced metastatic melanoma.

Study Objectives / Outcomes

Primary Objectives:

1) To evaluate the dose-limiting toxicities (DLT)
2) To determine the maximum tolerated dose (MTD)
3) To assess the pharmacodynamics (PHDY) and pharmacokinetics (PK) of CR011-vcMMAE when administered intravenously as a single agent

Secondary Objectives:
1) To evaluate the immune response to CR011-vcMMAE
2) To explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma
3) To establish the dose of CR011-vcMMAE recommended for future development

Study Status Information



Study Activation / Registration Date:	10/30/2006

IRB Review and Approval Date:	09/06/2006

Study Type:	Phase I

Recruitment Status:	Open

Projected Accrual:	135

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) Male or female with age >/= equal to 18 years.

2) A histologically or cytologically confirmed diagnosis of melanoma with evidence of progressive disease or new metastatic disease.

3) Unresectable stage III or stage IV melanoma.

4) At least one evaluable or measurable lesion evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST.

5) Subjects must have failed no more than 1 line of prior systemic cytotoxic therapy for metastatic disease. Subjects previously treated with biological therapies (e.g. interleukin-2 and non-cytotoxic monoclonal antibody) and/or immunotherapies (e.g. vaccines) are eligible for this trial.

6) Adequate bone marrow, hepatic and renal function including the following: (a) Leukocytes >/= 3000/mm^3, absolute neutrophil count >/= 1,500 cells/mm^3, platelets >/= 100,000/mm^3; (b) Hemoglobin >/= 10 g/dL; (c) Total bilirubin </= 1.5 x UNL; (d) AST (SGOT), ALT (SGPT) </= 3.0 x UNL </= 5.0 x UNL is acceptable if liver has tumor involvement; but at least 1/3 of the liver should be tumor free); (e) Serum creatinine </= 1.5 mg/dL or calculated creatinine clearance > 45 mL/min/1.73 m^2; (f) PT/aPTT < 1.5 x UNL or within therapeutic range in an anti-coagulation therapy such as Coumadin or Lovenox

7) Karnofsky performance status >/= 70%.

8) Estimated life expectancy greater than 3 months.

9) Signed informed consent approved by the Institutional Review Board.

10) The presence of at least one uni-dimensional measurable lesion. Lesions must be measured by CT-Scan or MRI according to RECIST.

Exclusion Criteria:

1) Subjects receiving cytotoxic chemotherapy, radiotherapy, immunotherapy, biological therapies (e.g. monoclonal antibody and interferon-alpha) or other investigational drugs less than 4 weeks prior to study drug therapy or with unresolved toxicity (> grade 1) from a prior treatment.

2) Active brain metastases. Subjects with brain disease that has been treated, who are off steroids for 4 weeks, show evidence of lesion regression and have no new disease after 8 weeks by CT scan or MRI will be allowed in this trial.

3) Major surgery or trauma (including biopsy of a visceral organ) within 4 weeks of study drug administration. Fine needle aspiration (FNA) biopsy will be allowed.

4) Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a history of a serious uncontrollable arrhythmia despite treatment, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.

5) Significant inflammatory illness, active autoimmune or immunodeficiency disease, and vascular or hemorrhagic disorders.

6) Subjects with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin. Compounds of similar composition include Auristatin PHE as an anti-fungal agent, Auristatin PE (TZT-1027, Soblidotin, NSC- 654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent.

7) Subjects unable to provide informed consent and/or unable to comply with the study or monitoring procedures.

8) Other malignancies except early stage (I or II) malignancy treated with curative intent more than 3 years previously without evidence of recurrence. Patients with a history of non-melanoma skin cancer are eligible regardless of the date of prior therapy.

9) Pregnant or breast-feeding women, and women of childbearing age and potential, and their male partners who are not willing to use effective contraception as safety in this population has not been assessed.

10) Known infection with HIV or as determined by history; known active hepatitis B or hepatitis C or as determined by history, as safety in these populations has not been assessed.

Links

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