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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00002952
First received: November 1, 1999
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

RATIONALE: Vaccines made from a tumor antigen gene may make the body build an immune response to kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cell to kill melanoma cells. Combining vaccine therapy with interleukin-12 may kill more melanoma cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy plus interleukin-12 in treating patients who have metastatic melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: MART-1 antigen
Biological: recombinant MAGE-3.1 antigen
Biological: recombinant interleukin-12
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Immunization With MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Clinical Response Rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 1997
Study Completion Date: November 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Melan-A peptide loaded PBMCs (sc, q3wk x 3), rhIL-12 (4 mcg, sc, days 1, 3 and 5 of every 3 wk cycle)
Biological: MART-1 antigen
Melan-A peptide loaded PBMCs (sc, q3wk x 3)
Biological: recombinant MAGE-3.1 antigen
Other Name: Melan-A peptide loaded PBMCs (sc, q3wk x 3)
Biological: recombinant interleukin-12
rhIL-12 (4 mcg, sc, days 1, 3 and 5 of every 3 wk cycle)

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002952

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00002952     History of Changes
Other Study ID Numbers: 9018, UCCRC-9018, UCCRC-8381, NCI-G97-1162
Study First Received: November 1, 1999
Last Updated: September 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-12
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014