Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma

NCT00019890 | Completed Phase 2

• 2 other identifiers: CDR0000067277NCI-99-C-0132
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.

Conditions

Stage IV Melanoma; Stage III Melanoma; Recurrent Melanoma

Keywords

adult solid tumor; body system/site cancer; cancer; melanoma; recurrent melanoma; skin tumor; solid tumor; stage III melanoma; stage IV melanoma; stage, melanoma

Interventions

dendritic cell-gp100-MART-1 antigen vaccine DRUG

sargramostim DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- High risk stage III melanoma (greater than 3 lymph nodes positive) OR completely resected metastatic melanoma within 6 months of surgery Disease free by CT scan HLA-A201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy No prior MART-1 or gp100 peptide immunization No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent systemic steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics No concurrent surgery --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiac disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active systemic infection No autoimmune disorders HIV negative Hepatitis B surface antigen negative

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

MeSH Terms

Conditions

Melanoma; Neoplasms; Skin Neoplasms

Interventions

sargramostim

Condition Hierarchy (Ancestors)

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

Study Officials

• Patrick Hwu

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Completion: March 1, 2007
• Last Updated: March 4, 2024

Record last verified: 2024-02