Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Melanoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00003552 |
Recruitment Status :
Terminated
First Posted : March 5, 2007
Last Update Posted : April 28, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients with metastatic melanoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stage IV Melanoma Recurrent Melanoma | Drug: allogeneic lymphocytes Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: fludarabine | Phase 1 Phase 2 |
OBJECTIVES: I. Identify an antitumor effect of allogeneic peripheral blood stem cell transplantation (PBSCT) in patients with metastatic melanoma.
II. Evaluate the safety and toxicity of a nonmyeloablative, low intensity, preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients.
III. Monitor engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in these patients.
IV. Investigate the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in this patient population.
V. Investigate the effect of lymphocyte infusions on donor-host chimerism in this patient population.
VI. Determine disease-free survival, overall survival, and mortality from the procedure or tumor progression in this patient population.
PROTOCOL OUTLINE: This is a dose-escalation study of a conditioning regimen. Patients receive 1 of 3 dose levels of chemotherapy prior to peripheral blood progenitor cell (PBPC) transplantation. Patients at dose level 1 receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1. Patients at dose level 2 receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2. Patients at dose level 3 receive cyclophosphamide IV over 1 hour daily on days -8 to -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.
Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2 if deemed necessary.
Patients with progressive disease on days 15-30, day 60, or day 100, without graft-versus-host disease, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician.
Patients are followed every 2 months for 6 months, every 3 months for the next 2 years, and then every 6 months until year 5 posttransplantation.
PROJECTED ACCRUAL:
A total of 40 patients will be accrued for this study.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation Followed by Allogeneic T-cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Melanoma |
Study Start Date : | January 1999 |
Actual Study Completion Date : | October 2002 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically confirmed metastatic melanoma not amenable to complete surgical resection and progressive despite immunotherapy and/or chemotherapy Bidimensionally evaluable clinically or radiographically HLA 6/6 or 5/6 matched sibling donor available No CNS metastases --Prior/Concurrent Therapy-- See Disease Characteristics At least 30 days since prior treatment for melanoma --Patient Characteristics-- Age: 18 to 60 Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 4 mg/dL Transaminases no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: Left ventricular ejection fraction greater than 40% Pulmonary: DLCO greater than 65% of predicted Other: HIV negative No major organ dysfunction precluding transplantation No other malignancies except basal cell or squamous cell skin cancer No psychiatric disorder or mental deficiency that would preclude study Not pregnant or nursing

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003552
United States, Maryland | |
National Heart, Lung, and Blood Institute | |
Bethesda, Maryland, United States, 20892 |
Study Chair: | Richard W. Childs | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00003552 |
Obsolete Identifiers: | NCT00001739 |
Other Study ID Numbers: |
CDR0000066609 NHLBI-98-H-0006 |
First Posted: | March 5, 2007 Key Record Dates |
Last Update Posted: | April 28, 2015 |
Last Verified: | December 2001 |
adult solid tumor body system/site cancer cancer melanoma recurrent melanoma |
skin tumor solid tumor stage IV melanoma stage, melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Cyclophosphamide Fludarabine |
Antilymphocyte Serum Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |