Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy and Interleukin-12 in Treating Patients With Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed Not specified NCI UCCRC-9018 UCCRC-8381, NCI-G97-1162, NCT00002952

Objectives

I.  Determine the safety and maximum tolerated dose level of the vaccine 
consisting of MAGE-3 or Melan-A (human tumor antigen genes) peptide-pulsed 
autologous peripheral blood mononuclear cells plus interleukin-12.

II.  Determine if the procedure results in successful immunization.

III.  Assess the response of the tumor to the vaccine.

Entry Criteria

Disease Characteristics:

Histologically confirmed metastatic melanoma

Patient must express HLA-A2 (a human leukocyte antigen)

Tumor must express MAGE-3 or Melan-A by polymerase chain reaction (PCR) 
analysis

No untreated brain metastases

Prior/Concurrent Therapy:

Biologic therapy:
 No concurrent immunosuppressive drugs
 At least 4 weeks since biologic therapy

Chemotherapy:
 At least 2 weeks since chemotherapy

Endocrine therapy:
 No concurrent systemic corticosteroids (except physiologic
  replacement doses)

Radiotherapy:
 At least 2 weeks since radiotherapy

Surgery:
 At least 2 weeks since surgery
 

Patient Characteristics:

Age:
 Not specified

Performance status:
 Karnofsky 70%-100%

Life expectancy:
 At least 12 weeks

Hematopoietic:
 Absolute neutrophil count at least 1,500/mm3
 Platelet count at least 100,000/mm3
 Hemoglobin at least 9 g/dL
 
Hepatic:
 Bilirubin no greater 1.5 times upper limit of normal (ULN)
 SGPT no greater than 2 times ULN
 
Renal:
 Calcium no greater than 11 mg/dL
 Creatinine no greater than 1.5 times ULN

Cardiovascular:
 No significant cardiovascular disease or cardiac arrhythmia
  requiring medical intervention

Other:
 Hepatitis B surface antigen negative 
 HIV negative
 No serious concurrent infection
 No clinically significant autoimmune disease
 No active gastrointestinal bleeding or uncontrolled peptic ulcer
  disease
 No history of inflammatory bowel disease
 No psychiatric illness that may interfere with compliance in study
 Not pregnant or nursing

Expected Enrollment

A total of 34 patients will be accrued for this study.

Outline

This is an open label, nonrandomized, single institution study.

Patients receive 3 initial courses of treatment consisting of 21 days each.  
Treatment consists of an immunization with MAGE-3 or Melan-A peptide-loaded 
autologous PBMC and interleukin-12 (IL-12) on the first day, IL-12 on days 3 
and 5, and 16 days of rest.  The first cohort is not administered IL-12 and 
the next cohorts are given escalating doses of IL-12.

The Phase II dose will be one dose level below the MTD.  Patients who have a 
tumor remission response or stable disease may continue treatment for up to 
one year.

Phase I completed as of 04/1999.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Thomas Gajewski, MD, PhD, Protocol chair		Ph: 773-702-4601; 888-824-0200 Email: tgajewsk@medicine.bsd.uchicago.edu

Registry Information
Official Title		Phase I/II Study of Immunization with MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients with Metastatic Melanoma
Trial Start Date		1997-01-15
Registered in ClinicalTrials.gov		NCT00002952
Date Submitted to PDQ		1997-06-10
Information Last Verified		2002-02-01
NCI Grant/Contract Number		CA14599