Abstract | PURPOSE: EXPERIMENTAL DESIGN: Eligibility criteria included measurable disease, no prior systemic therapy for a minimum of 4 weeks, and adequate marrow, renal, and hepatic function. Cyclophosphamide was administered once at a dose of 300 mg/m(2) i.v. on day -3 before the first dose of Melacine. Melacine was administered at a dose of 2 x 10(7) tumor cell equivalents per dose admixed with 0.25 ml of Detox-PC s.c. once a week on weeks 1-4 and week 6. Melacine maintenance was then given monthly from the 8th week, until progression or intolerable toxicity. IFN was started in the evening after the fourth dose of Melacine at a dose of 5,000,000 units/m(2) 3 times a week, and continued until progression. RESULTS: Forty-seven patients were enrolled, of whom 39 completed the full course and were considered evaluable. The toxicity of the regimen was minimal and consisted mainly of pain at injection sites and granulomas caused by Detox-PC, and constitutional symptoms attributable to IFN. In 39 evaluable patients, the overall objective response rate was 10.2%, but 64% of patients had stabilization of their disease for at least 16 weeks. The median time to disease progression in evaluable patients was 8 months [95% confidence interval (CI), 6-13 months]. Median survival time for all of the 47 patients enrolled was 12.5 months (95% CI, 8-15 months) with a median time to disease progression of 4 months (95% CI, 3-7 months). CONCLUSION: Despite a low objective response rate, this combination holds great promise because of its tolerability and the high proportion of prolonged durations of remission or disease stabilization that it elicited.
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Authors | Ulka Vaishampayan, Judith Abrams, Denise Darrah, Vicky Jones, Malcolm S Mitchell |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 8
Issue 12
Pg. 3696-701
(Dec 2002)
ISSN: 1078-0432 [Print] United States |
PMID | 12473578
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Review)
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Chemical References |
- Cancer Vaccines
- Interferon alpha-2
- Interferon-alpha
- Lymphokines
- Melacine
- Recombinant Proteins
- allogenic effect factor
- Cyclophosphamide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Cancer Vaccines
(administration & dosage)
- Cyclophosphamide
(administration & dosage)
- Female
- Humans
- Immunotherapy, Active
- Interferon alpha-2
- Interferon-alpha
(administration & dosage)
- Lung Neoplasms
(immunology, secondary, therapy)
- Lymphatic Metastasis
- Lymphokines
- Male
- Melanoma
(immunology, secondary, therapy)
- Middle Aged
- Recombinant Proteins
- Skin Neoplasms
(immunology, secondary, therapy)
- Survival Rate
- Treatment Outcome
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