MDACC Study Summary 2007-0450

Study Summary
No. 2007-0450:.......Melanoma......Wen-Jen Hwu......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2007-0450

Study Title:	A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) with Peginterferon Alfa-2b in Advanced Melanoma

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:	MGI Pharma Schering Plough

Phase of Study:	Phase I/Phase II	Return Visit:	Decitabine will be administered at the assigned dose intravenously over one hour daily for five days, days 1-5 (+/- one day) of a 28 day cycle for the duration of therapy. PEG-IFN a-2b will be administered sub q once weekly +/- one day.

Treatment Agents:	Decitabine PEG Interferon Alpha-2b	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of the first phase of this clinical research study is to find the
highest tolerable dose of decitabine and peginterferon alfa-2b that can be
given in combination to patients with melanoma. The safety of this drug
combination will also be studied.

The goals of the second phase are to learn if decitabine and peginterferon
alfa-2b combined can help to control melanoma, and to find out which doses are
more effective and/or better tolerated.

Study Objectives / Outcomes

Primary Objectives:

Phase I: To determine the safety and tolerability of the combination of decitabine and peginterferon alfa-2b at 6 pre-determined dose levels in patients with advanced melanoma.

Phase II: To determine the clinical benefit rate (stable disease + partial response + complete response), as measured by RECIST criteria, of patients with advanced melanoma treated with decitabine and peginterferon alfa-2b.

Secondary Objectives:

To determine the progression-free survival (PFS) of patients with advanced melanoma treated with combination decitabine and peginterferon alfa-2b.

To determine the overall survival (OS) of patients with advanced melanoma treated with combination decitabine and peginterferon alfa-2b.

To describe the effects of decitabine and interferon alfa-2b on DNA methylation and gene expression in patients' tumor and non-tumor tissues and their correlation with clinical outcomes.

To characterize the modulation of humoral and cellular immunity induced by the combination of decitabine and interferon alfa-2b in patients with advanced melanoma, and to correlate these results with clinical outcomes.

Study Status Information



Study Activation / Registration Date:	09/02/2008

IRB Review and Approval Date:	01/11/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

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 pathologically confirmed malignant melanoma that is unresectable stage III or stage IV.

2) Patients must have measurable disease as defined by RECIST criteria.

3) No more than one prior chemotherapy for unresectable stage III or IV melanoma.

4) Patients must be >/= 28 days beyond the last administration of anticancer therapy, and must have recovered from the toxicities of prior therapy. If the patient was recently treated with a nitrosurea, they must be >/= 42 days beyond the last administration.

5) Patients must have no other active malignancies. Patients with prior history of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible, if their disease has been inactive for 2 years prior to the time of study entry.

6) Patients must be >/= 18 years of age.

7) Patients must give written informed consent prior to initiation of therapy in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of this study and the risks associated with the therapy.

8) Women of childbearing potential (WOCBP) must not be pregnant (negative urine HCG within 2 weeks of treatment) or lactating. A WOCBP is defined as a woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.

9) Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 3 months after completing or discontinuing treatment.

10) Patients must have ECOG performance status 0 or 1.

11) Patients must have adequate organ and marrow function, measured within 14 days of study entry, as defined below: All Patients: - Absolute neutrophil count >/=1,500/uL - Platelets >/=100,000/uL - Creatinine (serum) </= 2.0 mg/dL - Total bilirubin </= 1.5 mg/dL - AST(SGOT)/ALT(SGPT) </= 2.5 X Institutional Upper Limit of Normal (IULN)

12) Patients with any number of prior targeted or cytokine therapies, but no more than two chemotherapy containing regimens.

Exclusion Criteria:

1) Patients with active autoimmune disorders or who are receiving immunosuppressive therapy (including steroids or methotrexate) for any indication are excluded. An exception may be made, by the PI, to include patients with adrenal insufficiency requiring physiologic steroid hormone replacement only.

2) Patients who have previously received adjuvant high dose interferon.

3) Patients may not receive any other investigational agents within four weeks of study entry. Patients may not receive any other investigational agents while on study.

4) Patients who have had major surgery within 2 weeks prior to entering the study, or have otherwise not adequately recovered from prior surgery.

5) Patients who have had palliative radiation therapy within 2 weeks prior to entering the study.

6) Patients with brain metastases.

7) Patients with a history of active ischemic heart disease or cerebro-vascular disease, congestive heart failure (NYHA class >2) or anginal syndrome requiring ongoing medical treatment.

8) Patients with MI, stroke, or TIA within the last 6 months.

9) Patients with a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol.

10) Patients with a history of CNS demyelinating, inflammatory disease or hereditary or acquired peripheral neuropathy.

11) Patients with known history of HIV and hepatitis infection or any other significant medical or surgical condition or psychiatric disorder that may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study combination.

12) Patients with thyroid dysfunction not responsive to therapy.

Links

Registration Number: NCT00791271
Study Information on Clinical Trials Registry (clinicaltrials.gov)