Title

Using BCG as Adjuvant in Addition to Primary Therapy for Stage I-III Melanoma (Mature Results of a Phase III Study)

Sponsor

Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

Bacillus Calmette-Guerin (BCG) is known to bring about an immune response that may improve resistance to certain tumors tested in the laboratory. The purpose of this study was to evaluate the effectiveness of BCG, alone or in combination with another chemotherapy drug, dacarbazine, to prevent relapse and improve survival for patients with high-risk melanoma who had been surgically treated. Dacarbazine is a chemotherapy drug used for more advanced stages of melanoma.

Results

No benefit was shown using BCG alone or in combination with dacarbazine when treating stage I-III melanoma and its use is not recommended.

Conclusion

There are unlikely to be subsequent studies using this approach as it quite conclusive from this study and others that this approach will not be successful. Further studies with this approach are not warranted.

Start Date

1974

Stop Date

1978

Number of Participating Patients

734

Eligibility Requirements

Patients had melanoma and had surgical treatment. Some patients had melanoma that had not spread. Others had melanoma that had spread into lymph nodes.

Study Design

Patients were divided into four groups and then assigned to one of two sub-groups. In the first sub-group, patients received either observation alone or received the drug BCG. In the second sub-group, patients received either BCG alone or in combination with dacarbazine. Treatment was given in eight-week cycles for 18 months.

Side Effects

The most frequent side effects were nausea and vomiting, and inflammation and abscesses at the injection site (infection).

References

Agarwala SS, Neuberg D, Park Y, Kirkwood JM. Mature Results of a Phase III Randomized Trial of bacillus Calmette-Guerin (BCG) versus Observation and BCG plus Dacarbazine versus BCG in the Adjuvant Therapy of American Joint Committee on Cancer Stage I-III Melanoma (E1673). Cancer 2004 Apr 15;100(8):1692-8. (E1673) [Manuscript published 4/15/2004]

National Cancer Institute Patient Summary

Not Available.

Reviewed by

Sanjiv S. Agarwala, MD, University of Pittsburgh; John Kirkwood, MD, University of Pittsburgh; Cheryl K. Rutledge, BSN, Indiana University Cancer Center; Mary Lou Smith, ECOG Patient Representative

Released August 16, 2006 (Revised July 13, 2006)