Clinical trial of combination chemotherapy and specific active immunotherapy in disseminated melanoma

Newlands, E S; Oon, Chong Jin; Roberts, J.T.; Elliott, Patricia; Mould, Richard F.; Topham, C.; Madden, F.J.F.; Newton, K. A.; Westbury, G

doi:10.1038/bjc.1976.140

Cited by 31 publications

(13 citation statements)

References 12 publications

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“…Although there was no evidence of an effect on survival, the incidence of objective regressions in patients with early dissemination (i.e. confined to skin, lymph nodes or lungs) was distinctly higher than historical or literature controls; an observation similar to that of Newlands et al (1976 and control arms are identical. We felt obliged to abandon the study on ethical grounds, in view of the very short relapsefree interval in the patients receiving irradiated allogeneic tumour cells (5 months).…”

mentioning

confidence: 70%

Specific active immunotherapy does not prolong survival in surgically treated patients with stage IIB malignant melanoma and may promote early recurrence

Hedley¹,

McElwain²,

Currie³

1978

Br J Cancer

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Summary.-A prospective trial with concurrent controls was designed to assess the effects of specific active immunotherapy in patients receiving intermittent cytotoxic chemotherapy (DTIC+Vincristine) as an adjuvant to surgery in Stage IIB malignant melanoma. The treated group received monthly irradiated allogeneic melanoma cells and BCG, and the controls BCG only. Sixteen patients in the treatment arm had a median relapse-free interval of 5 months, compared to 8 months in 12 controls given chemotherapy and BCG, and because of this we felt that continuation of the study was unjustified on ethical grounds. Although all the controls who relapsed did so at distant sites, 7/11 patients given specific active immunotherapy relapsed initially within the lymphatic drainage area of the primary tumour. The median intervals from starting treatment to relapse at distant sites, and the median survival were identical in the 2 groups.We conclude that immunotherapy comprising irradiated allogeneic melanoma cells as employed in this study does not prolong survival in surgically treated Stage IIB malignant melanoma and may even promote early, local relapse.

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mentioning

confidence: 70%

Specific active immunotherapy does not prolong survival in surgically treated patients with stage IIB malignant melanoma and may promote early recurrence

Hedley¹,

McElwain²,

Currie³

1978

Br J Cancer

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“…The use of historical controls by Gutterman, et al [4] and Hedley et al [5] compromises the clarity of their observation. Although, the study of Newlands et al [10] employed a randomized prospective control, the inclusion as partial responders of patients with progressive disease at nonsignal sites makes their data difficult to interpret. Although Gutterman et al [4] report an improved survival with chemoimmunotherapy, the randomized prospective trial of Newlands et al [10] failed to confirm this observation.…”

Section: Resultsmentioning

confidence: 99%

A phase III comparison of methyl-CCNU + vincristine with or without BCG + allogeneic tumor cells in metastatic melanoma

Mastrangelo

Bellet

Berd

1979

Cancer Immunol Immunother

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“…Specific active immunotherapy trials in this country include those of Simmons et al (1978), Morton et al (1978), Arlen and Hollinshead (Arlen et al 1977), Laucius andMastrangelo (Lauciusetal. 1977,Mastrangelo et al 1978), and in Great Britain those of McIUmurray et al (1977), Hedley et al (1977Hedley et al ( , 1978 and Newlands et al (1976). The specific active immunotherapy reagent varied and included unmodified and nodified tumor cells as in the studies of Morton, Simmons, Newlands, Hedley or Laucius. In most of these studies, cells were either neuraminidase treated, virus treated, or irradiated.…”

Section: Specific Aetive Immunotherapymentioning

confidence: 99%

Immunotherapy of Melanoma

Nathanson¹

1979

J Cutan Pathol

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Malignant melanoma is a disease characterized by clinical evidence of host defense, possibly immunologically mediated. It is a disease which tends to be refractory to both radiotherapy and chemotherapy. Immunotherapy has been used in three phases of the disease. 1. Intralesional immunotherapy with a nonspecific immune adjuvant in patients with local intradermal or soft tissue recurrence. This treatment produces approximately 15% regression of both injected and uninjected lesions, and about 60% regression of injected lesions only. Both clinical and laboratory evidence suggests that this regression is immunologically mediated. 2. Patients with surgical removal of all clinically demonstrable tumor, either primary disease alone or regional node recurrence, active nonspecific, and specific, immunotherapy has been used in an adjuvant setting. There is considerable controversy about the benefits accruing to such immunotherapy, but most large scale prospective and randomized studies have suggested that if benefit does result it is modest in degree and probably cannot be measured in terms of increase in cure rate. 3. Immunotherapy has also been used as a nonspecific active adjuvant to single drug or polychemotherapy in patients with disseminated melanoma. Whereas complete response rate may be slightly increased by this maneuver there is no convincing evidence that immunotherapy markedly increases the total objective response rate to polychemotherapy, and survival is only marginally superior when immunotherapy is added to chemotherapy in this setting. Further studies need to be done with active specific immunotherapy with tumor cell membrane extracts; as an adjuvant in patients with minimal body burden of tumor cells; and to study the inaction between chemotherapy and immunotherapy in this disease. Furthermore, studies of chemically defined fractions of either bacterial cell wall or tumor cell extracts must be evaluated both in terms of their ability to augment cell mediated immune responses in the melanoma patient, and also in terms of their ability to induce objective benefit for the patient. The possible use of immunotherapy in patients with primary melanoma has been briefly explored but needs further study. Possible additive effects with radiotherapy and immunotherapy should also be looked at in this disease utilizing high dose fractions and other new forms of radiotherapeutic technique.

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Clinical trial of combination chemotherapy and specific active immunotherapy in disseminated melanoma

Cited by 31 publications

References 12 publications

Specific active immunotherapy does not prolong survival in surgically treated patients with stage IIB malignant melanoma and may promote early recurrence

Specific active immunotherapy does not prolong survival in surgically treated patients with stage IIB malignant melanoma and may promote early recurrence

A phase III comparison of methyl-CCNU + vincristine with or without BCG + allogeneic tumor cells in metastatic melanoma

Immunotherapy of Melanoma

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