Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Melanoma

NCT00004022 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000067241P30CA022453WSU-C-1403-MENCI-G99-1565
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery in treating patients who have stage III or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

autologous tumor cell vaccine BIOLOGICAL

muromonab-CD3 BIOLOGICAL

therapeutic autologous lymphocytes BIOLOGICAL

surgical procedure PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven stage III or IV malignant melanoma * Resectable disease * At least 50,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0 or 1 Life expectancy: * At least 6 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least lower limit of normal * No active or recent uncontrolled bleeding Hepatic: * Bilirubin normal * SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: * Creatinine normal Other: * Negative stool guaiac * No impaired immunity * No uncontrolled diabetes * No active uncontrolled infections * No other serious disease * No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * At least 2 weeks since prior therapy and recovered

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; FANG vaccine; Muromonab-CD3; Surgical Procedures, Operative

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Immunoglobulin G; Immunoglobulin Isotypes; Serum Globulins; Globulins

Study Officials

• Roy D. Baynes, MD, PhD, FACP

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 13, 2004
• Study Start: June 1, 1997
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: April 5, 2013

Record last verified: 2013-04

Locations

US (1)