MDACC Study Summary 2006-0816

Study Summary
No. 2006-0816:.......Melanoma......Wen-Jen Hwu......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2006-0816

Study Title:	An Exploratory Study of Adjuvant Therapy of Pegylated Interferon-Alfa 2b Plus Melanoma Peptide Vaccine in Patients with Resected Stage II and III (N1a, N2a) 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:	Merck

Phase of Study:	Phase I	Return Visit:	Every 3 weeks

Treatment Agents:	gp100 peptide Peg Intron	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the best dosing schedule of a combined treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that may help improve immune response in patients that had Stage II or Stage III melanoma and are free of the disease. The safety and tolerability of this drug combination will also be studied.

Study Objectives / Outcomes

Primary Objective:

To explore the biological optimal dosing schedule of PEG Intron, when combined with melanoma peptide
gp100 vaccine, and defined as the most effective in eliciting T-lymphocyte immune response to the
melanoma peptide, while it is safe with acceptable toxicity.

Secondary Objectives:

1. To evaluate immune response in peripheral blood mononuclear cells (PBMC) obtained through apheresis at baseline and after completion of 24-weeks of treatment and by simple venipuncture every 3-weeks during treatment.

2. To assess the safety and tolerability of gp100 in combination with three different dosing schedules of PEG Intron.

Study Status Information



Study Activation / Registration Date:	03/10/2009

IRB Review and Approval Date:	08/31/2007

Study Type:	Other

Recruitment Status:	Closed

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 be free of disease after surgical resection for AJCC stage II or III (N1a) melanoma (T2b, T3a, T3b, T4a, T4b and N1a or N2a). Diagnosis must be confirmed by the Pathology Department of MD Anderson Cancer Center.

2) Patients must be HLA-A0201 positive.

3) Patients must be fully recovered from surgery, for at least one month, but not more than 90 days after surgery and before study entry.

4) Patients must have no other 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 skin cancer are eligible. Patients with other malignancies are eligible, if they have been continuously disease-free for 5 years prior to the time of study entry.

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

6) Patients must give signed written informed consent.

7) Women of childbearing potential (WOCBP) must not be pregnant (negative urine HCG within 2 weeks of treatment) or lactating. A WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).

8) 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. Simultanous use of two contraceptive methods such as, IUD or condom and contraceptive jelly is considered the accepted method of contraception.

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

10) Patients must have WBC >/= 3,000/mm3, platelet count >/= 100,000/mm3, and hemoglobin >/= 9 g/dL or 5.6 mmole/L obtained within 2 weeks of study entry.

11) Patients must have AST, ALT, LDH, alkaline phosphatase, and bilirubin within institutional upper limit (IUL) of normal and serum creatinine < 2.0 mg/dl or < 140 micromol/L all obtained within 2 weeks of study entry. Patients with Gilbert's Disease may have bilirubin </= to 2 x (ULN).

12) Patients must have a CT of chest, abdomen, pelvis, and a MRI or CT scan of the brain performed within 4 weeks of study entry.

Exclusion Criteria:

1) Patients with clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or any distant metastatic disease.

2) Patients with autoimmune disorders or receiving immunosuppressive therapy including chemotherapy, steroids or methotrexate.

3) Patients requiring consistent use of antihistamines or non-steroidal anti-inflammatory drugs.

4) 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.

5) Patients have 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. Any questionable patients will be reviewed by the investigator or attending physician.

6) Patients having prior radiotherapy, chemotherapy or any immunotherapy including, tumor vaccines, interferon, interleukins, levamisole or other biologic response modifiers for any type of cancer.

7) Patients with a history of CNS demyelinating, inflammatory disease or hereditary or acquired grade 2 or higher peripheral neuropathy.

8) Patients with any other significant medical or surgical condition or psychiatric disorder, which includes any serious psyciatric illness that has not been adequately controlled despite intervention (with our without medication) with known history of HIV or hepatitis infection may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study compound.

9) Patients with thyroid dysfunction not responsive to therapy.

10) Patients with pre-existing psychiatric condition including, but not limited to: a. History of severe depression, including the following: 1) Hospitalization for depression 2) Electroconvulsive therapy for depression 3) Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions. b. Suicidal or homicidal ideation and/or suicidal or homicidal attempt. c. History of severe psychiatric disorders (eg. psychosis, post-traumatic stress disorder or mania). d. Past history or current use of lithium and/or antipsychotic drugs

Links

Registration Number: NCT00861406
Study Information on Clinical Trials Registry (clinicaltrials.gov)