Vaccine Therapy in Treating Patients With Metastatic Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022568
First received: August 10, 2001
Last updated: December 17, 2013
Last verified: December 2003
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: recombinant vaccinia-TRICOM vaccine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma.
  • Determine the clinical toxic effects of this vaccine in these patients.
  • Determine the safety of this vaccine in these patients.
  • Determine the clinical response of these patients to this vaccine.
  • Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3 vaccinations. Patients with stable or responding disease may receive an additional course of vaccinations.

Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Quality of life is assessed at baseline, at each vaccine administration, and at study completion.

Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 6-12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma
  • Lesion(s) must be accessible to percutaneous injection
  • Measurable lesion(s)

    • At least 1.0 cm
  • Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed

    • At least 6 weeks since prior definitive therapy (surgery or radiotherapy)
  • No untreated or edematous metastatic brain lesions or leptomeningeal disease
  • No ascites or pleural effusions

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm3
  • Platelet count at least 100,000/mm3
  • Absolute granulocyte count at least 3,000/mm3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Direct bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN
  • No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications)
  • No hepatic insufficiency
  • No alcoholic cirrhosis

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No renal insufficiency

Cardiovascular:

  • No congestive heart failure
  • No serious cardiac arrhythmias
  • No evidence of recent prior myocardial infarction on EKG
  • No clinical coronary artery disease

Pulmonary:

  • No chronic obstructive pulmonary disease

Immunologic:

  • No prior eczema
  • HIV negative
  • No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds)
  • No clinical or laboratory evidence of an underlying immunosuppressive disorder
  • No active or chronic infections
  • No significant allergy or hypersensitivity to eggs

Other:

  • No active seizure disorders
  • No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free
  • No evidence of bone marrow toxicity
  • No other concurrent medical illness that would preclude study
  • No other contraindications to vaccinia virus administration
  • No encephalitis
  • Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior vaccinia immunization required (e.g., smallpox vaccination)
  • More than 8 weeks since prior immunotherapy and recovered
  • No prior therapy with live vaccinia virus vector

Chemotherapy:

  • More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids
  • No concurrent systemic corticosteroids
  • No concurrent steroids

Radiotherapy:

  • See Disease Characteristics
  • More than 2 weeks since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics
  • More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered

Other:

  • No concurrent immunosuppressive drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022568

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Investigators
Study Chair: Howard L. Kaufman, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022568     History of Changes
Other Study ID Numbers: CDR0000068831, CPMC-IRB-14387, AECM-01-003, NCI-3353
Study First Received: August 10, 2001
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

ClinicalTrials.gov processed this record on April 22, 2014