Phase I/II Study of Immunization With MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Melanoma


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

Phase I/II Study of Immunization With MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Melanoma


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.

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.

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

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Response Rate

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Thomas F. Gajewski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9018

NCT ID:

NCT00002952

Start Date:

January 1997

Completion Date:

November 2002

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location
University of Chicago Cancer Research Center Chicago, Illinois  60637