Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma

NCT00004148 | Completed Phase 1

• 3 other identifiers: CDR0000067380AECM-99-101NCI-T99-0006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.

Biological: recombinant vaccinia-B7.1 vaccine

Interventions

recombinant vaccinia-B7.1 vaccine BIOLOGICAL

Arm I

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases * Accessible for injection * Lesions must measure at least 1 cm * Patients with no prior treatment allowed * Patients must have one of the following as proof of prior vaccinia immunization: * Physician certification * Recollection and appropriate vaccination scar site * No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease * No ascites or pleural effusions * No leukemia or lymphoma PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-1 Karnofsky 80-100% * Life expectancy: Greater than 3 months * WBC greater than 4,000/mm3 * Platelet count greater than 100,000/mm3 * Hemoglobin greater than 10g/dL * Bilirubin less than 1.5 mg/dL * Transaminases no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications * No alcoholic cirrhosis * Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min * No congestive heart failure * No serious cardiac arrhythmias * No recent prior myocardial infarction * No clinical coronary artery disease * No chronic obstructive pulmonary disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No seizure disorders * No underlying immunosuppressive disorder * No autoimmune disease HIV negative * No skin diseases * No open wounds * No eczema or other contraindications to vaccinia virus administration * Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment * No significant allergy or hypersensitivity to eggs * No active or chronic infections * No concurrent medical illness * No other significant medical disease which would increase risk to patient * No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: * At least 8 weeks since prior immunotherapy and recovered * No prior live pox virus vector * No more than 2 prior chemotherapy regimens * At least 4 weeks since prior chemotherapy and recovered * At least 4 weeks since prior systemic corticosteroids * No systemic corticosteroids for concurrent illness * No concurrent immunosuppressive steroids * At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity) * At least 6 months since prior radiotherapy for brain metastases and recovered * At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease * At least 6 months since prior surgery for brain metastases and recovered * No concurrent immunosuppressive drugs

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

Study Sites (1)

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Related Publications (2)

• Kaufman HL, Deraffele G, Mitcham J, Moroziewicz D, Cohen SM, Hurst-Wicker KS, Cheung K, Lee DS, Divito J, Voulo M, Donovan J, Dolan K, Manson K, Panicali D, Wang E, Horig H, Marincola FM. Targeting the local tumor microenvironment with vaccinia virus expressing B7.1 for the treatment of melanoma. J Clin Invest. 2005 Jul;115(7):1903-12. doi: 10.1172/JCI24624. Epub 2005 Jun 2.

  PMID: 15937544 RESULT

• Kaufman HL, Conkright W, Divito J Jr, Horig H, Kaleya R, Lee D, Mani S, Panicali D, Rajdev L, Ravikumar TS, Wise-Campbell S, Surhland MJ. A phase I trial of intra lesional RV-B7.1 vaccine in the treatment of malignant melanoma. Hum Gene Ther. 2000 May 1;11(7):1065-82. doi: 10.1089/10430340050015374. No abstract available.

  PMID: 10811235 RESULT

MeSH Terms

Conditions

Melanoma

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

• Howard L. Kaufman, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: February 20, 2004
• Study Start: October 1, 1999
• Primary Completion: April 1, 2006
• Last Updated: February 11, 2013

Record last verified: 2006-06

Locations

US (1)