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Home > "S" Clinical Trials Conditions > Stem Cell Transplant for Malignant Melanoma  Stem Cell Transplant for Malignant Melanoma
Stem Cell Transplant for Malignant Melanoma
For Condition: Graft vs Host Disease,Melanoma,Neoplasm Metastasis
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: Malignant melanoma is an uncontrolled growth of melanocytes, the cells which normally give pigment to the skin. These cancerous cells can spread (metastasize) from the original kidney tumor site to other organs such as the bones, lymph nodes, liver, lungs, and brain. Once these organs become involved, the uncontrolled growth of cells can lead to organ failure and death. There are several treatments available for malignant melanoma that can be successful. However, once malignant melanoma has spread to other organs, it is rarely curable. Surgery can be used to treat malignant melanoma but in many patients the disease has spread too much to be removed by surgery. Medical treatment with chemotherapy can be used to treat malignant melanoma, but it has been relatively unsuccessful for patients whose cancer has spread to other organs. Autologous bone marrow transplants (BMT) have been studied for the treatment of metastatic melanoma. This form of therapy is where marrow cells or stem cells are collected from the patient and used to rescue bone marrow function after very high doses of chemotherapy. The effects of this kind of therapy do not last long and do offer any survival advantage over treat with standard chemotherapy. Allogenic bone marrow transplants (BMT) have been used to treat cancers of the blood and bone marrow. Allogenic transplants are cells collected from relatives of the patient. However, allogenic BMTs are usually combined with powerful doses of chemotherapy and radiation therapy. These additional treatments are associated with toxic side effects, often making BMTs too dangerous to attempt in many patients. Researchers are interested in learning more about the potential benefits of modified bone marrow transplant (allogenic stem cell transplantation) for patients with advanced malignant melanoma. In this study researchers plan to treat patients with advanced malignant melanoma with transplanted stem cells from a genetically matched brother or sister. These stem cells are healthy cells collected from the bone marrow of the patient's relative. Once the stem cells are transplanted they help to make new blood cells. In addition, immune factors found in the transplant can work to destroy cancerous cells. In order to avoid the toxic side effects normally associated with BMT, the stem cell transplant will be combined with low intensity chemotherapy. The majority of the cancer killing effect will be the responsibility of the stem cell transplant rather than the chemotherapy.
Details: The current treatment of patients with stage IV malignant melanoma is unsatisfactory. No chemotherapeutic agent, alone or in combination has been shown to prolong survival in patients with metastatic melanoma. In vitro and clinical studies have shown that melanoma cells are immunogenic and can be killed by tumor-specific cytotoxic lymphocytes. These findings form the basis of immunotherapeutic strategies for melanoma. However, such approaches are currently ineffective for the majority of patients with metastatic melanoma. For many adult leukemias allogeneic bone marrow transplantation (BMT) is the only curative modality. In vitro studies have implicated donor-derived CD4 and CD8 positive lymphocytes with specific reactivity for the patient's leukemia and a powerful anti-leukemic, or graft versus leukemia (GVL) effect. This GVL effect is best seen in patients with relapsed CML after bone marrow transplantation where a single infusion of donor lymphocytes can induce complete and lasting remission. Melanoma cells as known targets for autologous T-cell attack could similarly be susceptible to a powerful allogeneic graft versus tumor effect. In this study we treat patients with progressive metastatic melanoma with an allogeneic stem cell transplant from an HLA identical sibling in an attempt to exploit the immunogenicity of melanoma cells. The allogeneic immune system established after transplant would have the advantage of not being "tolerized" to the patient's tumor and may be capable of recognizing alloantigens on tumor cells which are not part of the repertoire of the host's immune surveillance. A low intensity, nonmyeloablative conditioning regimen will be used to minimize transplant associated toxicity, while providing adequate immunosuppression to allow stem cell and lymphocyte engraftment. During this study should the conditioning regimen engraftment rate be established to be less than 80%, the conditioning regimen will be escalated in a phase I fashion until a dose level which achieves at least 80% engraftment is established. T-cell replete, donor-derived granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells (PBSC) will be used to establish hematopoietic and lymphoid immune reconstitution. We will infuse lymphocytes in patients with less than 100% donor T-cell chimerism as an attempt to prevent graft rejection. Cyclosporine and Mycophenolate Mofetil (MMF) prophylaxis of graft versus host disease (GVHD) will be reduced in patients who develop progressive melanoma in the absence of GVHD to enhance a possible graft-versus-tumor (GVT) effect. Should disease progression continue (in the absence of GVHD), patients will receive an infusion of donor lymphocytes as a further attempt to obtain a GVT effect. The end points of this study are tumor regression, engraftment, degree of donor-host chimerism, incidence of acute and chronic GVHD, transplant related morbidity and mortality as well as disease-free and overall survival.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: PATIENT: Patient must be between 18-60 years of age to be eligible. Patients with a biopsy proven metastatic melanoma, not amenable to complete surgical resection, progressive despite immunotherapy and/or chemotherapy and bidimensionally evaluable clinically or radiographically are eligible. Patients must not have received treatment for melanoma within 30 days to be eligible. Patients must be HIV negative to be eligible. Patients must have ECOG performance status of 1 or less to be eligible. Patients must have no major organ dysfunction precluding transplantation to be eligible. Patients must have a DLCO greater than 65 percent predicted to be eligible. Patients must have a left ventricular ejection fraction greater than 40 percent to be eligible. Patients must have a HLA 6/6 or 5/6 matched family related donor available to be eligible. Patients must give informed consent. Patients must have a signed durable power of attorney. Patients must not be pregnant or lactating. Patient must not have ECOG performance status of 2 or more. Psychiatric disorder or mental deficiency of the patient or donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Patients must have no major anticipated illness or organ failure incompatible with survival from BMT where survival is considered insufficient to assess transplant outcome (i.e. less than 6 months). Patients with serum creatinine greater than 2.5 mg/dl are not eligible. Patients with serum bilirubin greater than 4 mg/dl, transaminases greater than 3 times the upper limit of normal are not eligible. Patients with history of other malignancies except basal cell or squamous carcinoma of the skin are not eligible. Patients with a disease which is limited and amendable to complete surgical resection are not eligible. Patients with a lack of evidence of progressive disease are not eligible. Patients with disease which is not evaluable clinically or radiographically are not eligible. Patients with evidence for CNS metastatic disease are not eligible. Patients with greater than 15 percent involvement of liver parenchyma with metastatic disease are not eligible. DONOR: Donor must be an HLA 6/6 or 5/6 matched sibling. Donor must be fit to receive G-CSF and give peripheral blood stem cells (normal blood counts, normotensive, no history of stroke) to be eligible. Donor must give informed consent. Donor must not be pregnant. Donor must be HIV negative and HBsAg negative. Donor must have no history of malignancy within 5 years except basal cell or squamous carcinoma of the skin. Donors unfit to receive G-CSF and undergo apheresis (uncontrolled hypertension, history of stroke, thrombocytopenia) are not eligible.
Total Enrollment: 40
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980006; 98-H-0006
Study Start Date: October 8, 1997
Record last reviewed: October 10, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001739
Other Graft Vs Host Disease Studies:
1. Treatment of Patients with Metastatic Renal Cell Carcinoma with Neutralizing Antibody to Vascular Endothelial Growth Factor (VEGF)
2. A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
3. A Phase I Study of Isolated Hepatic Perfusion with Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver
4. Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma.
5. Phase I Trial in Patients with Metastatic Melanoma of Immunization with a Recombinant Fowlpox Virus Encoding the gp100 Melanoma Antigen
Related Studies:
Other Graft vs Host Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Stem Cell Transplant for Malignant Melanoma
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