Biological Therapy in Treating Patients With Metastatic Melanoma
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00002786
First received: November 1, 1999
Last updated: May 6, 2010
Last verified: May 2010
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Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: aldesleukin Biological: therapeutic tumor infiltrating lymphocytes |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA |
Resource links provided by NLM:
Further study details as provided by Fred Hutchinson Cancer Research Center:
| Estimated Enrollment: | 20 |
| Study Start Date: | October 1995 |
| Study Completion Date: | March 2006 |
OBJECTIVES:
- Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma.
- Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients.
- Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients.
OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for approximately 1 year after the last infusion.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histopathologically proven metastatic melanoma
- No CNS metastases
- HLA-A2 positive
- Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT scan, or MRI)
- Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- Karnofsky 80-100%
Life expectancy
- More than 16 weeks
Hematopoietic
- WBC greater than 4,000/mm^3
- Absolute neutrophil count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hematocrit greater than 30%
Hepatic
- Bilirubin no greater than 1.6 mg/dL
- SGOT no greater than 150 IU (or no greater than 3 times normal)
- Prothrombin time no greater than 1.5 times control
Renal
- Creatinine no greater than 2.0 mg/dL
- Calcium no greater than 12 mg/dL
Cardiovascular
- No congestive heart failure
- No clinically significant hypotension
- No symptoms of coronary artery disease
- No arrhythmia on EKG requiring drug therapy
Pulmonary
- No severe chronic obstructive pulmonary disease
- FEV_1 at least 1.0 L
- DLCO at least 45% of predicted
Other
- No active infection or oral temperature greater than 38.2 degrees C within 72 hours of study
- No systemic infection requiring chronic maintenance or suppressive therapy
- HIV negative
- No history of seizures
- No retinitis or choroiditis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use adequate contraception
- Peripheral blood samples available weekly for 4 consecutive weeks
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since other prior immunotherapy
Chemotherapy
- 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease
- At least 4 weeks since prior standard or investigational chemotherapy
Endocrine therapy
- At least 4 weeks since prior steroid therapy
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- At least 4 weeks since other prior investigational drug therapy and recovered
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002786
Locations
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
| Study Chair: | Cassian Yee, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002786 History of Changes |
| Obsolete Identifiers: | NCT00029419 |
| Other Study ID Numbers: | 1017.01, FHCRC-1017.01, NCI-V96-0920, CDR0000064846 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 6, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
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 |
Aldesleukin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013