Complete Remission of Widely Metastatic Melanoma: A Case Report

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Complete Remission of Widely Metastatic Melanoma: A Case Report
Complete Remission of Widely Metastatic
                      Melanoma: A Case Report
                                                            Mitchell Gaynor, MD, et. al.*
            Melanoma has the potential to metastasize to any organ in the body.
            Patients with metastatic melanoma usually have a median survival of
6-9 months. A complete response was achieved when low dose IL-2 and GM-CSF
were combined with high doses of intravenous vitamin C and
glutathione, low doses of Temodar administered on a metronomic schedule, with
magnolia extract. The clinical, radiological and histopathological features are
discussed.

Melanoma has the potential to metas-             pain. On physical exam, the patient ap-          patient had another large metastatic lesion
tasize to any organ in the body Patients         peared toxic and was febrile. There was a        in her left leg. She underwent a biopsy and
with metastatic melanoma usually have a          5x7cm, multilobulated, exophytic tumor           debulking of a metastatic melanoma in the
median survival of 6-9 months. We report         with necrosis overlying the skin of the left     superficial dermis with clear margins. She
a complete remission in an 80-year-old           anterior tibial region. A number of smaller      had a CT scan of the chest, abdomen and
patient with malignant melanoma. The             cutaneous metastases were present proxi-         pelvis in September 2010 that revealed a
patient presented with pulmonary metasta-        mally (Figure 1).                                7x9 mm nodule at the right lung base con-
ses and a history of multiple resections for       She had inguinal lymphadenopathy and           sistent with new metastasis (Figure 2).
local recurrence and in-transit metastasis.      4+ edema of the left lower extremity. The          MRI of the left calf showed several new
The following case seems worthy of a re-         tumor was inflamed with exudative weep-          subcutaneous tumor deposits consistent
port because of a CR (complete response)         ing along with erythema and swelling in          with in-transit metastasis (Figure3).
when low dose IL-2 and GM-CSF were               the surrounding area.                              After refusing ipilimumab because of po-
combined with high doses of Intravenous              The patient’s relevant medical history       tential side effects, the patient presented at
vitamin C and glutathione, low doses of          dates from 2006 when she noted a lump            our integrative clinic to discuss treatment
Temodar administered on a metronomic             in her left leg near the heel. She initially     options for the progression of her disease.
schedule, with magnolia extract. The clini-      deferred evaluation of this, but eventually      She was initially started on antibiotics (Cef-
cal, radiological and histopathological fea-     presented to a dermatologist where on Oc-        triaxone and Levofloxacin for severe left
tures are discussed.                             tober 2006, she had a biopsy of the lesion       lower extremity cellulitis). A week later,
                                                 that showed invasive melanoma. Subse-            leukine (250 mcg SQ twice weekly), vi-
Case Presentation                                quently, she underwent a surgical consul-        tamin C (50 grams IV weekly), proleukin
  An 80-year old female with a past medi-        tation and later a wider excision with a         (1million units SQ twice weekly), temozol-
cal history of stage IV melanoma meta-           sentinel node biopsy. The pathology report       amide (20 mg 5 days per week), acitretin
static from a left foot primary with multiple    from the heel specimen described residual        (25mg orally three times per week) and
prior resections of in-transit metastasis and    malignant invasive melanoma in situ and          Magnolia extract 200 mg (containing 90%
right lung metastasis presented to the clinic    invasive to a Breslow depth of 2.4 mm of         honokiol and magrolol) daily by mouth,
on Dec 2011. She complained of extreme           thickness, Clark level IV. Surgical margins      were added to her treatment regimen. The
weakness, pruritus, rashes and left heel         were clear, and the tumor was noted to be        patient slowly improved over a few weeks
                                                 present throughout the cicatrix. The sen-        as her cellulitis resolved. The vitamin C
                    Figure 1                     tinel node biopsies from the left inguinal       was given weekly for one year and con-
 5x7 cm. exophytic, fungating, necrotic mass
   over the left anterior tibial area prior to
                                                 area were negative for metastatic disease.       tinued every other week since September
                    therapy.                       The patient had no evidence of disease         2010. Glutathione 3000 mg. was given IV
                                                           over the next 2 years. By Novem-       weekly for one year and continued every
                                                           ber 2008, she underwent an FNA         other week since September 2010. The
                                                           biopsy of a left heel nodule near      leukine and proleukin were continued
                                                           her initial resection site that con-   twice weekly since September 2010. After
                                                           firmed metastatic melanoma. On         3months of treatment, the patient under-
                                                           December 2008, she underwent           went PET- CT of the body and extremities
                                                           a left heel excision of a recurrent    in April 2012 that demonstrated significant
                                                           melanoma lesion. The patient 6         resolution of previous metastatic lung le-
                                                           months later developed in-transit      sion (Figure 4) and complete resolution of
                                                           metastases, which led to mul-          the subcutaneous and superficial lesions in
                                                           tiple small subcutaneous nodules       her left leg (Figure 5).
                                                           along the left anterior shin for         Follow up PET-CT on October 2012 re-
                                                           which she had a biopsy that also       vealed no evidence of metastatic disease.
                                                           confirmed metastatic malignant         There has been complete regression of
                                                           melanoma. In February 2010, the        the metastatic melanoma lesions in the

 Reprint - Cancer Strategies Journal - Spring 2014 - www.cancerstrategiesjournal.com                                                          1
Complete Remission of Widely Metastatic Melanoma: A Case Report
stage IV disease, the sites of    cancer cell types are killed only at con-
                                                                  metastasis and level of lac-      centrations approaching Mm range.13 As
                                                                  tate dehydrogenase are the        established by seminal studies by Chen et
                                                                  most important predictors of      al, vitamin C in concentrations higher than
                                                                  survival. Patients with distant   1Mm can cause build up of hydrogen per-
                                                                  skin or subcutaneous sites or     oxide (H2O2) which is preferentially toxic
                                                                  distant lymph nodes have          towards tumor cells.14 Though the mys-
                                                                  1year survival rate of 59%.       tery of cytotoxicity to cancer cells remain
                                                                  Patients with lung metastasis     unsolved, possibilities include stimulatory
                                                                  have a 10-year survival rate      effects on apoptotic pathways, accelerated
                                                                  of less than 47%, whereas         pro oxidant damage that cannot be re-
                                                                  patients with metastasis to       paired by tumor cells and increased oxida-
                                                                  other visceral sites like the     tion of ascorbic acid at high concentration
                                                                  brain have a 10 year survival     in plasma to unstable metabolite dehydro-
                                                                  rate of < 30%.5 Cutane-           ascorbate which can be toxic. Overexpres-
                                                                  ous melanoma metastasizes         sion of COX2, VEGF (a potent angiogenic
                                                                  more commonly to the lungs.       factor) and type I insulin like growth factor
                    Figure 2                                      A single focus of pulmonary       (IGF) receptor are important for prolifera-
 Chest CT scan showing 7x9 mm. pulmonary          metastasis is associated with a better sur-       tion and protection from apoptosis in ma-
nodule (shown by arrow) at right lung base sus-
 picious for potential metastasis from primary    vival than presence of multiple foci. Treat-      lignancies.15,16 When vitamin C is used in
        melanoma in the left lower leg.           ment of melanoma in its early stages is           the treatment of malignant melanoma, it
                                                  predominantly surgical and consists of ex-        suppresses proliferation of melanoma cell
left lower leg (Figure 6). Currently, the pa-     cision of primary tumor with a 1-2 cm mar-        line SK MEL2 via down regulation of IGF
tient’s clinical status remains excellent as      gin and radical lymphadenectomy if the            expression, inhibition of COX2 expression
she continues in complete remission.              sentinel lymph nodes harbor metastasis.           and therefore suppression of VEGF pro-
                                                  Ipilimumab is a biologic response modifier        duction. There have been several reports
Discussion                                        which blocks cytoxic T-lymphocyte antigen         of clinical evidence that has shown benefits
  Malignant melanoma (MM) is a fatal cu-          4 has an overall response rate of 11% and         of combining Ascorbate with chemothera-
taneous neoplasm, arising from the pig-           improved median overall survival from 6.4         py.17
ment producing cells (melanocytes) of the         months to 10.1 months for patients with             Glutathione is an abundant natural tri-
epidermis. Of the seven most common               metastatic melanoma.6 Patients with meta-         peptide found within almost all cells. It is
cancers in the US, melanoma is the only           static disease with BRAF V600E mutation           an important antioxidant that prevents
one whose incidence is increasing. Be-            have an average progression free response         damage to important cellular component
tween 2000 and 2009, incidence climbed            (PFS) of 6.7 months, compared to 2.9              caused by reactive oxygen species such
1.9 percent annually.1 Melanoma accounts          months in controls7,8 and a 50% response          as free radicals and peroxides. It is also
for less than five percent of skin cancer         rate utilizing BRAF mutation specific inhib-      involved in the modulation of immune re-
cases, but the vast majority of skin cancer       itors such as vemurafenib and dabrafanib.         sponse and detoxification of xenobiotics. In
deaths.2 It is usually described as an ir-          Regarding its role in cancer treatment,         healthy living cells and tissues, more than
regular dark skin lesion that may have ar-        vitamin C has been debated for many               90% of total glutathione is in the reduced
eas of varying color in sun-exposed areas         years. Emerging evidence indicates that           state (GSH) and less than 10% exists in di-
or in unexposed areas. Early diagnosis is         ascorbic acid in cancer treatment deserves        sulfide form (GSSG). An increase in GSSG
crucial, as metastatic or advanced disease        re-examination. Cameron and Pauling re-
is associated with poorer prognosis. The          ported in 1976 and 1978 that high dose                               Figure 3
                                                                                                    MRI combined with PET-CT of the extremities
commonest site of presentation for men            vitamin C (typically 10gms/day by IV in-          showing in-transit metastasis of melanoma in
tends to be the trunk, and for women is the       fusion for about 10days and thereafter                  the left lower leg represented by
lower limb.3                                      orally) increased the average survival of                hyper-metabolic yellow areas.

   The most common cause of death in              advanced cancer patients
melanoma is widespread metastasis.4 Stag-         and for a small group of
ing in melanoma is based on primary tu-           responders, survival was
mor thickness, ulceration, lymph node and         increased up to 20 times
distant metastasis. The American Joint            longer than controls.9 Cam-
Commission on Cancer (AJCC) TNM                   eron and Pauling suggested
system is the most commonly used mela-            that Vitamin C increased
noma staging system. Stage I and II of this       extracellular collagen and
system are comprised of patients without          strengthened the extracel-
regional or distant metastasis. Stage III pa-     lular matrix, thus walling in
tients have metastasis either in the regional     tumors.10 Laboratory data
lymph nodes or intra-lymphatic sites. Stage       show that ascorbic acid is
IV patients have visceral metastasis in dis-      toxic to a variety of cancer
tant sites. The thickness and ulceration of       cell lines.11,12 Extracellular
melanoma are important in criteria assess-        concentrations as low as
ing survival in patients with localized dis-      100-200µM are toxic to
ease (Stage I and Stage II). In patients with     some cell lines, but many

 2                                        Reprint - Cancer Strategies Journal - Spring 2014 - www.cancerstrategiesjournal.com
Complete Remission of Widely Metastatic Melanoma: A Case Report
to GSH ratio is considered oxidative stress,      (MMP-9), vascular endothelial
which is implicated in cancer progression.18      growth factor (VEGF), and cell
The intracellular depletion of glutathione        cycle regulatory genes (cy-
leading to cell death has been extensively        clin D1 and c-myc). Honokiol
researched for decades. GSH levels in hu-         downregulates the expres-
man tissue normally range from 0.1mM,             sion of the abovementioned
most concentrated in liver, spleen, kidney,       products and thus prevents
lens, erythrocytes and leucocytes. Oxida-         proliferation and metastasis of
tive stressors that can deplete GSH include       cancer.26,27,28 It also potentiates
ultraviolet rays and other radiation, viral       apoptosis induced by TNF and
infections, environmental toxins, heavy           chemotherapeutic agents.29
metals, surgery, inflammation, burns, sep-          In patients with advanced
tic shock, and dietary deficiencies of GSH        melanoma, treatment with te-
precursors.19,20 The immune system func-          mozolomide is associated with
tion is dependent upon the lymphoid cells         greater improvements in over-
having a delicately balanced, adequate            all survival.30 Temozolomide is
level of glutathione. Certain functions           a novel oral alkylating agent,                                      Figure 5
                                                                                                      MRI combined with PET-CT of the extremi-
such as orderly DNA synthesis are exqui-          which appears to exert its therapeutic ben-       ties showing complete resolution of in-transit
sitely sensitive to reactive oxygen species       efit through DNA methylation and there-           metastasis seen in the left lower extremity of
and therefore improved by high levels of          fore triggering the death of neoplastic cells.                   previous scan.
antioxidant glutathione. Certain signaling        Its acceptable safety profile and predictable
pathways, in contrast, are enhanced by            pharmacokinetics make temozolomide an
oxidative conditions and favored by low           excellent candidate for inclusion in combi-      centrations, the normal melanocytes were
glutathione levels. IL-2 dependent func-          nation therapies for advanced metastatic         not affected. EGCG treatment of the mela-
tions including T-cell proliferation, cytotox-    melanoma. Temozolomide, which is 100%            noma cell lines resulted in decreased cell
ic T-cell activity, lymphokine activated killer   orally bioavailable, allows for outpatient       proliferation and induction of apoptosis via
cells and natural killer cells are particularly   treatment. This is particularly desirable        downmodulation of anti-apoptotic protein
sensitive to glutathione depletion.23 It has      for patients with advanced melanoma, a           Bcl2, upregulation of proapoptotic Bax and
been demonstrated that exogenous, extra           group with a short life expectancy and a         activation of caspases.39 EGCG also causes
cellular glutathione induces apoptosis in         low rate of response to treatment. In clini-     significant induction of cell cycle arrest via
ovarian cancer cell lines by inducing ex-         cal studies, temozolomide was well toler-        modulations in the cki-cyclin-cdk network.
pression of the P53 and P21 tumor sup-            ated and demonstrated rapidly reversible,        Thus, EGCG, alone or in conjunction with
pressor genes.24                                  mild to moderate myelosuppression.31             current therapies, could be useful for the
  Honokiol and magnolol (isomer of Ho-              However given this patient’s concurrent        management of melanoma. Sinecatechine
nokiol) have shown to inhibit skin tumor          infection and advanced age, conventional         (trade name Veregen) is an ointment of
growth and invasion.25 The nuclear tran-          dosing of temozolamide was contraindicat-        catechins (55% epigallocatechin gallate)
scription factor nuclear factor (NF-Kb) is        ed. Metronomic dose chemotherapy has             extracted from green tea and other com-
involved in the expression of several genes       been found to be well tolerated,32 and have      ponents. It was the first botanical prescrip-
whose products are involved in tumori-            both pro-apoptopic33 and anti-angiogenic         tion drug approved by the US Food and
genesis. These include antiapoptotic genes        effects34 in multiple tumor types.               Drug Administration, for treatment of geni-
(survivin, TRAF, Bcl-2, bcl-xl), cyclooxy-          Based on several clinical studies, vitamin     tal warts caused by the Human Papilloma
genase (COX-2), matrix metalloproteinase          A has been observed to interfere with the        Virus.40
                                                  carcinogenic process in different ways.
                  Figure 4                        Inhibition of malignant melanoma cell            Conclusion
 Chest CT scan showing virtual resolution of      proliferation through Fas death receptor           Late presentation of metastatic mela-
      previously seen metastatic right
             pulmonary lesion
                                                  pathway mediated cell apoptosis,35 inhibi-       noma is common, and should be remem-
                                                           tion of proliferation of melanoma       bered in patients with a distant history of
                                                           cells through cell cycle arrest36 ap-   melanoma. Follow-up is necessary in or-
                                                           pear to be some of the proposed         der to diagnose potential dissemination or
                                                           mechanisms of vitamin A against         secondary sites of the disease. In stage-IV
                                                           malignant melanoma.                     melanoma, Temodar, IL-2 therapy com-
                                                             Natural plant extracts, such as       bined with retinoic acid, vitamin C, topical
                                                           polyphenolic antioxidants found         sinecatechin, magnolol, glutathione and
                                                           in green tea and grape seed, have       sargramostim demonstrates a promising al-
                                                           been shown to inhibit tumor angio-      ternative/complementary regimen to stan-
                                                           genesis and tumor growth through        dard regimens for treatment of metastatic
                                                           a number of mechanisms.37 Epigal-       melanoma. Temodar was added on met-
                                                           locatechin-3-gallate (EGCG), the        ronomic schedule for its broadspectrum
                                                           major catechin (flavonol) in green      antitumor activity via promoting apoptosis
                                                           tea was found to result in a dose-      and inhibiting angiogenesis with limited
                                                           dependent decrease in the viability     side effects. Magnolol, vitamin C, vitamin
                                                           and growth of melanoma cells.38         A, and topical sinecatechin were included
                                                           Interestingly, at similar EGCG con-     because of their proapoptotic properties

 Reprint - Cancer Strategies Journal - Spring 2014 - www.cancerstrategiesjournal.com                                                             3
Complete Remission of Widely Metastatic Melanoma: A Case Report
*Authors: Gaynor, Mitchell L., Gopal-              References for this article may be found at at
                                                                                                                          http://www.cancerstrategiesjournal.com/
                                                                       arathinam, Rajesh., Kline, Mitchell.
                                                                                                                          ReferencesVolume2Issue2.pdf

                                                                                          Figures and artwork included by permission of the authors.

                                                                                                         Mitchell L. Gaynor, MD
                                                                          Mitchell L. Gaynor MD is Founder and President of Gaynor Integrative Oncology (www.
                                                                          dr.gaynor.com). Assistant Attending Physician at New York Presbyterian Hospital/Weill Cor-
                                                                          nell Medical Center, and Clinical assistant Professor of Medicine at Weill Medical College.
                                                                          He has held the position of Director of Medical Oncology at The Strang Cancer Prevention
                                                                          Center where he still serves as a consultant. He is also former Medical Director and Direc-
                                                                          tor of Medical Oncology at the Weill Cornell Medical Center Institute for Complementary
                    Figure 6                                              and Integrative Medicine. He has served on the Executive Review Panel at the Department
     There was complete resolution of the
     melanoma lesion seen initially on the                                of Defense – Alternative Medicine for Breast Cancer Sector and the Smithsonian Institute’s
            left anterior tibia area.                                     Symposium on New Frontier in Breast Cancer and the Environment. He is a frequent speak-
                                                                          er and lecturer at hospitals, conferences, and universities throughout American and abroad.
against melanoma cells. IL-2 even in low                                  Dr. Gaynor is the best selling author of four books and a CD focusing on healing, health, the
doses regulates cellular immune response.                                 environment, and cancer prevention.
Glutathione has immune-stimulating and                                      Dr. Gaynor has been consecutively listed in The Best Doctors in New York since 1997
pro-apoptopic effects. Sargramostim stim-                                 and has served on the Board of Advisors for Healthy Living Magazine, the Sass Medical
ulates the bone marrow to produce natural                                 Foundation, as well as the Editorial board of Integrative Cancer Therapies. After receiving
killer cells. This patient has remained in                                his medical degree from the University of Texas – Southwestern Medical School in Dallas,
complete remission for 25 months and is                                   TX, he was a clinical fellow in hematology-oncology at the New York Hospital-Cornell Medi-
tolerating the regimen without side effects.                              cal Center and a post-doctorate fellow in molecular biology at Rockefeller University. He is
Further investigation of this combination                                 board certified in medical oncology, hematology and internal medicine. He is a member of
of low dose immune modulating agents,                                     the American Society of Clinical Oncology, the American College of Physicians and the New
chemotherapy and bioactive nutrients is                                   York Academy of Sciences.
warranted.

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Complete Remission of Widely Metastatic Melanoma: A Case Report
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                                                                     Spring 2014
                                                                Volume 11, Issue 2
Complete Remission of Widely Metastatic Melanoma: A Case Report Complete Remission of Widely Metastatic Melanoma: A Case Report Complete Remission of Widely Metastatic Melanoma: A Case Report Complete Remission of Widely Metastatic Melanoma: A Case Report
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