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Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma
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Purpose
RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
| Melanoma (Skin) | Biological: therapeutic autologous lymphocytes Drug: fludarabine phosphate | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma |
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2003 |
| Study Completion Date: | October 2008 |
OBJECTIVES:
Primary
- Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with stage IV melanoma.
- Determine the duration of in vivo persistence of these CTL clones in these patients.
Secondary
- Determine the antitumor effect of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL) clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over 30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable toxicity. Patients also receive fludarabine IV once daily on days 14-18.
Patients are followed for up to 1 year.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed metastatic melanoma
- Stage IV disease
- HLA-A2 or -A3-expressing disease
- Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)
-
No CNS metastases
- Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- Karnofsky 80-100%
Life expectancy
- More than 6 months
Hematopoietic
- Platelet count > 100,000/mm^3
- Absolute neutrophil count > 2,000/mm^3
Hepatic
- SGOT no greater than 3 times upper limit of normal
- Bilirubin no greater than 1.6 mg/dL
- INR no greater than 1.5 times normal
Renal
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No congestive heart failure
- No clinically significant hypotension
- No symptoms of coronary artery disease
- No cardiac arrhythmia by EKG requiring drug therapy
Pulmonary
- No clinically significant pulmonary dysfunction
- FEV_1 at least 1.0 L*
- DLCO at least 45%* NOTE: *For patients with a history of pulmonary dysfunction
Immunologic
- No active infection
- No oral temperature greater than 38.2°C within the past 48 hours
- No systemic infection requiring chronic maintenance or suppressive therapy
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy)
Chemotherapy
- At least 3 weeks since prior chemotherapy (standard or experimental)
Endocrine therapy
- No concurrent steroids
Radiotherapy
- At least 3 weeks since prior radiotherapy
Surgery
- Not specified
Other
- At least 3 weeks since prior immunosuppressive therapy
- No concurrent pentoxifylline
- No other concurrent investigational agents
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00317759
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Principal Investigator: | Cassian Yee, MD | Fred Hutchinson Cancer Research Center |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00317759 History of Changes |
| Other Study ID Numbers: |
1796.00 FHCRC-1796.00 CDR0000327817 ( Registry Identifier: PDQ ) |
| Study First Received: | April 24, 2006 |
| Last Updated: | September 30, 2015 |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Fludarabine Fludarabine phosphate |
Vidarabine Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on July 19, 2017