Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT00002817 | Unknown Phase 1

• 3 other identifiers: CDR0000064975JMC-94-0843NCI-H96-0965
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill melanoma cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients with metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

sargramostim BIOLOGICAL

vaccinia-GM-CSF vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven melanoma that is considered surgically incurable Dermal, subcutaneous, or lymph node metastases required At least 3 lesions evaluable and accessible for injection and biopsy One lesion at least 10 mm in diameter No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 3 times ULN Immunologic: Clinical evidence of immune response required within 4 days of smallpox vaccination At least 1 positive cutaneous delayed-type hypersensitivity response to 1 of the following: Microbial recall antigens Dinitrofluorobenzene after sensitization Purified protein derivative of tuberculin following BCG vaccination No altered immunocompetence (e.g., immune deficiency disease or immunosuppressive therapy) in patient or household contacts No allergy to any of the following: Polymyxin B sulfate Streptomycin sulfate Chlortetracycline hydrochloride Neomycin sulfate No history of eczema or other exfoliative skin conditions in patient or household contacts HIV negative Other: No other malignancy within the past 3 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or prostate Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 8 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent or imminent steroid therapy Radiotherapy: At least 8 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael J. Mastrangelo, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 22, 2004
• Study Start: April 1, 1996
• Last Updated: January 10, 2014

Record last verified: 2002-05

Locations

US (1)