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Active specific immunotherapy with vaccinia melanoma oncolysate
M K Wallack1, S D Scoggin, M Sivanandham
1Department of Surgery, St. Vincent's Hospital and Medical Center, New York, NY 10011.
Abstract:
Based on antitumor effects observed with vaccinia virus infected tumor cell lysate in animal models, adjuvant immunotherapeutic clinical trials were undertaken in patients with melanoma using vaccinia virus infected melanoma oncolysate (VMO). Preliminary clinical trials showed that the VMO is safe except minimal side effects such as mild fever, pain, and tenderness at the site of VMO injection, and mild lymphadenopathy. The effective dose of VMO was investigated in a following trial using 0.05 to 2.0 mg doses of VMO. Clinical responses and laboratory monitoring of melanoma-specific antibody responses decided the 2 mg dose of VMO is optimal for future trials. In all the clinical trials, patients showed moderate responses and their postimmune sera contained melanoma-specific antibodies. In a Phase II clinical trial completed August 1985 19 of 39 stage II patients had a disease-free mean survival time of 24.6 months, statistically significant compared with historical controls. Because of compelling evidence of significant clinical responses in patients treated with VMO adjuvant immunotherapy in the Phase II trial, a prospective randomized multi-institutional double-blind Phase III adjuvant VMO immunotherapeutic trial using adjuvant therapy of vaccinia virus alone as control, was recently initiated. Results of this trial are anxiously anticipated.
Insights
Vaccinia virus infected melanoma oncolysate (VMO) shows promise as an adjuvant immunotherapy for melanoma. Clinical trials indicate VMO is safe and elicits melanoma-specific antibodies, improving disease-free survival in Stage II patients.
Area of Science:
- Oncology
- Immunotherapy
- Virology
Background:
- Antitumor effects of vaccinia virus infected tumor cell lysate were observed in animal models.
- Adjuvant immunotherapeutic clinical trials were initiated in melanoma patients using vaccinia virus infected melanoma oncolysate (VMO).
Purpose of the Study:
- To evaluate the safety and efficacy of VMO as an adjuvant immunotherapy for melanoma.
- To determine the optimal dose of VMO for future clinical trials.
- To assess the clinical response and melanoma-specific antibody production in patients treated with VMO.
Main Methods:
- Preliminary safety and tolerability assessments of VMO.
- Dose-ranging studies (0.05 to 2.0 mg) to identify the effective VMO dose.
- Phase II clinical trial in Stage II melanoma patients.
- Monitoring of clinical responses and melanoma-specific antibody levels.
- Initiation of a Phase III randomized, double-blind trial comparing VMO to vaccinia virus alone.
Main Results:
- VMO was found to be safe with minimal side effects (mild fever, pain, tenderness, lymphadenopathy).
- The optimal dose of VMO was determined to be 2 mg.
- Patients demonstrated moderate clinical responses and developed melanoma-specific antibodies.
- In a Phase II trial, 19 of 39 Stage II patients achieved a statistically significant mean disease-free survival of 24.6 months.
Conclusions:
- VMO is a safe and potentially effective adjuvant immunotherapy for melanoma.
- The 2 mg dose of VMO is recommended for further investigation.
- Significant improvements in disease-free survival suggest VMO's therapeutic potential.
- Results from the ongoing Phase III trial are anticipated to further validate VMO's efficacy.