Know Cancer

or
forgot password

Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen


Phase 1
16 Years
N/A
Not Enrolling
Both
Lung Cancer, Adult Soft Tissue Sarcoma, Colorectal Cancer, Bone Cancer, Ovarian Sarcoma, Melanoma, Colon Cancer, Rectal Cancer, Breast Cancer, Eye Cancer, Uterine Sarcoma

Thank you

Trial Information

Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen


OBJECTIVES: I. Determine the toxicity profile of MAGE-12 peptide vaccine in patients with
refractory metastatic cancer that expresses MAGE-12 antigen.

II. Determine whether an immunologic response, as measured by an in vitro sensitization
assay, can be obtained after administration of this regimen in these patients.

III. Determine a frequency of administration for this regimen based on immunologic response
in these patients.

IV. Determine other immunologic parameters in these patients treated with this regimen.

V. Determine the clinical response rate in these patients treated with this regimen.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to disease
(metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of two
treatment arms.

Arm I: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant
subcutaneously (SC) weekly for 4 doses.

Arm II: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant SC
once every 3 weeks for 4 doses.

Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8
hours, beginning on the day after each immunization and continuing for up to 4 days.
Patients achieving stable disease or a mixed, partial, or complete response continue on
vaccine therapy alone for up to 24 total doses.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL:

A total of 26-56 patients (13-28 per treatment arm) will be accrued for this study within 1
year.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically documented metastatic cancer of one of the
following types: Cutaneous melanoma Ocular melanoma Colorectal carcinoma Non-small cell
lung cancer Breast carcinoma Sarcoma HLA-Cw*0702 positive MAGE-12 expression by RT-PCR
amplified tissue analysis Failed prior standard therapy Measurable or evaluable disease No
renal carcinoma Hormone receptor status: Not specified --Prior/Concurrent Therapy--
Biologic therapy: At least 3 weeks since prior biologic therapy for cancer No other
concurrent biologic therapy for cancer Chemotherapy: At least 3 weeks since prior
chemotherapy for cancer and recovered No concurrent chemotherapy for cancer Endocrine
therapy: At least 3 weeks since prior hormonal therapy for cancer No concurrent hormonal
therapy for cancer No concurrent steroids Radiotherapy: At least 3 weeks since prior
radiotherapy for cancer and recovered No concurrent radiotherapy for cancer Surgery: Prior
surgery for cancer allowed --Patient Characteristics-- Age: 16 and over Sex: Male or
female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy:
Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
90,000/mm3 Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal
Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac ischemia,
myocardial infarction, or cardiac arrhythmias (if receiving interleukin-2 (IL-2) therapy)
Pulmonary: No obstructive or restrictive pulmonary disease (if receiving IL-2 therapy)
Other: Not pregnant Negative pregnancy test Fertile patients must use effective
contraception No active systemic infections No autoimmune disease, known immunodeficiency
disease, or active primary or secondary immunodeficiency Hepatitis B surface antigen
negative HIV negative No other active major medical illnesses (if receiving IL-2 therapy)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Francesco M. Marincola

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068173

NCT ID:

NCT00020267

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • Adult Soft Tissue Sarcoma
  • Colorectal Cancer
  • Bone Cancer
  • Ovarian Sarcoma
  • Melanoma
  • Colon Cancer
  • Rectal Cancer
  • Breast Cancer
  • Eye Cancer
  • Uterine Sarcoma
  • Ewing's family of tumors
  • adult soft tissue sarcoma
  • adult solid tumor
  • body system/site cancer
  • bone cancer
  • breast cancer
  • cancer
  • childhood cancer
  • childhood solid tumor
  • ciliary body and choroid melanoma, medium/large size
  • colon cancer
  • colorectal cancer
  • extraocular extension melanoma
  • eye cancer
  • female reproductive cancer
  • gastrointestinal cancer
  • genetic condition
  • intraocular melanoma
  • lung cancer
  • male breast cancer
  • melanoma
  • metastatic osteosarcoma
  • metastatic tumors of the Ewing's family
  • muscle cancer
  • musculoskeletal cancer
  • non-small cell lung cancer
  • osteosarcoma
  • osteosarcoma/malignant fibrous histiocytoma of bone
  • ovarian sarcoma
  • rectal cancer
  • recurrent adult soft tissue sarcoma
  • recurrent breast cancer
  • recurrent colon cancer
  • recurrent intraocular melanoma
  • recurrent melanoma
  • recurrent non-small cell lung cancer
  • recurrent osteosarcoma
  • recurrent rectal cancer
  • recurrent tumors of the Ewing's family
  • recurrent uterine sarcoma
  • skin tumor
  • solid tumor
  • stage IIIB, IV, recurrent, and metastatic breast cancer
  • stage IV adult soft tissue sarcoma
  • stage IV breast cancer
  • stage IV colon cancer
  • stage IV melanoma
  • stage IV non-small cell lung cancer
  • stage IV rectal cancer
  • stage IV uterine sarcoma
  • stage IVA adult soft tissue sarcoma
  • stage IVB adult soft tissue sarcoma
  • stage, Ewing's family of tumors
  • stage, adult soft tissue sarcoma
  • stage, breast cancer
  • stage, colon cancer
  • stage, intraocular melanoma
  • stage, melanoma
  • stage, non-small cell lung cancer
  • stage, osteosarcoma
  • stage, rectal cancer
  • stage, uterine sarcoma
  • thorax/respiratory cancer
  • uterine sarcoma
  • Bone Neoplasms
  • Osteosarcoma
  • Breast Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Eye Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Sarcoma

Name

Location

Surgery BranchBethesda, Maryland  20892