Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Schering-Plough
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00861406

Purpose

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:

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

Condition	Intervention	Phase
Melanoma	Drug: Pegylated Interferon-Alfa 2b (PEG Intron) Drug: GP-100 Peptide Vaccine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Exploratory Study of Adjuvant Therapy of Pegylated Interferon-Alfa 2b Plus Melanoma Peptide Vaccine in Patients With Resected, Intermediate-Thickness, Node-Negative Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Maximum T-cell levels for each patient during the 24 weeks of treatment. [ Time Frame: Patient's T-cell levels will be assessed every 3 weeks using a tetramer assay. ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Pegylated Interferon alfa-2b (Once week x 4 weeks) + GP-100 Peptide	Drug: Pegylated Interferon-Alfa 2b (PEG Intron) Group 1: 6 mcg/kg by injection under skin once weekly for 4 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 20 weeks. Group 2: 6 mcg/kg by injection under skin once weekly for 8 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 16 weeks. Group 3: 6 mcg/kg by injection under skin once weekly for 12 weeks followed by Maintenance Phase of 3 mcg/kg weekly for 12 weeks. Drug: GP-100 Peptide Vaccine Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.
Group 2: Experimental Pegylated Interferon alfa-2b (Once week x 8 weeks) + GP-100 Peptide	Drug: Pegylated Interferon-Alfa 2b (PEG Intron) Group 1: 6 mcg/kg by injection under skin once weekly for 4 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 20 weeks. Group 2: 6 mcg/kg by injection under skin once weekly for 8 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 16 weeks. Group 3: 6 mcg/kg by injection under skin once weekly for 12 weeks followed by Maintenance Phase of 3 mcg/kg weekly for 12 weeks. Drug: GP-100 Peptide Vaccine Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.
Group 3: Experimental Pegylated Interferon alfa-2b (Once week x 12 weeks) + GP-100 Peptide	Drug: Pegylated Interferon-Alfa 2b (PEG Intron) Group 1: 6 mcg/kg by injection under skin once weekly for 4 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 20 weeks. Group 2: 6 mcg/kg by injection under skin once weekly for 8 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 16 weeks. Group 3: 6 mcg/kg by injection under skin once weekly for 12 weeks followed by Maintenance Phase of 3 mcg/kg weekly for 12 weeks. Drug: GP-100 Peptide Vaccine Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.
Patients must be HLA-A0201 positive.
Patients must be fully recovered from surgery, for at least one month, but not more than 90 days after surgery.
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.
Patients must be >/= 18 years of age.
Patients must give signed written informed consent.
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).
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. Simultaneous use of two contraceptive methods such as, IUD or condom and contraceptive jelly is considered the accepted method of contraception.
Patients must have ECOG performance status 0 or 1.
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.
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 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:

Patients with clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or any distant metastatic disease.
Patients with autoimmune disorders or receiving immunosuppressive therapy including chemotherapy, steroids or methotrexate.
Patients requiring consistent use of antihistamines or non-steroidal anti-inflammatory drugs.
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.
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.
Patients having prior radiotherapy, chemotherapy or any immunotherapy including, tumor vaccines, interferon, interleukins, levamisole or other biologic response modifiers for any type of cancer.
Patients with a history of CNS demyelinating, inflammatory disease or hereditary or acquired grade 2 or higher peripheral neuropathy.
Patients with any other significant medical or surgical condition or psychiatric disorder, 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.
Patients with thyroid dysfunction not responsive to therapy.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861406

Contacts

Contact: Wen-Jen Hwu, MD, PhD

713-792-2921

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Wen-Jen Hwu, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Schering-Plough

Investigators

Principal Investigator:

Wen-Jen Hwu, MD, PhD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Wen-Jen Hwu, MD, PhD/Professor )
Study ID Numbers:	2006-0816
Study First Received:	March 12, 2009
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00861406 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Melanoma
Stage II melanoma
Pegylated Interferon-alfa 2b
PEG Interferon alfa-2b
PEG Intron
Melanoma Peptide Vaccine

GP100 Vaccine
gp100
peptide vaccine
Leukapheresis
Immune-cell response

Study placed in the following topic categories:

Interferon-alpha
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Interferons
Adjuvants, Immunologic
Angiogenesis Inhibitors
Antiviral Agents
Melanoma

Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Peginterferon alfa-2b
Neuroepithelioma
Nevus
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Angiogenesis Modulating Agents
Growth Inhibitors
Interferon-alpha

Neoplasms by Histologic Type
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Peginterferon alfa-2b
Interferon Alfa-2a
Interferon Alfa-2b

ClinicalTrials.gov processed this record on September 10, 2009