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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00438984 |
Purpose
RATIONALE: Biological therapies, such as therapeutic autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor cells. Giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin may be an effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects of giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin in treating patients with stage IV melanoma
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Melanoma Stage IV Melanoma |
Drug: cyclophosphamide Biological: therapeutic autologous lymphocytes Biological: aldesleukin Other: immunohistochemistry staining method Procedure: biopsy Other: laboratory biomarker analysis Other: immunologic technique Genetic: polymerase chain reaction |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma |
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2006 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (chemotherapy, immunosuppressive, lymphocytes)
All patients receive high-dose cyclophosphamide IV on days -3 and -2 and autologous antigen-specific cytotoxic CD8+ T-lymphocyte clones IV over 30-60 minutes on day 0. COHORT I: Beginning within 6 hours of T cell infusion, patients receive low-dose aldesleukin SC twice daily on days 0-14. COHORT II: Beginning within 6 hours of T cell infusion, patients receive high-dose aldesleukin IV 3 times daily on days 0-5. |
Drug: cyclophosphamide
Given IV
Other Names:
Biological: therapeutic autologous lymphocytes
Given IV
Other Names:
Biological: aldesleukin
Given IV or SC
Other Names:
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Procedure: biopsy
Optional correlative studies
Other Name: biopsies
Other: laboratory biomarker analysis
Correlative studies
Other: immunologic technique
Correlative studies
Other Names:
Genetic: polymerase chain reaction
Correlative studies
Other Name: PCR
|
PRIMARY OBJECTIVES:
I. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients receiving autologous CD8+ antigen-specific T cell clones following cyclophosphamide conditioning and post-infusion IL-2.
II. To assess the duration of in vivo persistence of adoptively transferred CD8+ T cell clones.
SECONDARY OBJECTIVES:
I. Evaluate the antitumor effect of adoptively transferred CD8+ antigenspecific cytotoxic t lymphocytes (CTL) clones following cyclophosphamide conditioning and post-infusion IL-2.
OUTLINE:
Patients are assigned 1of 2 treatment cohorts.
All patients receive high-dose cyclophosphamide intravenously (IV) on days -3 and -2 and autologous antigen-specific cytotoxic CD8+ T lymphocyte clones IV over 30-60 minutes on day 0.
COHORT I: Beginning within 6 hours of T cell infusion, patients receive low-dose aldesleukin subcutaneously (SC) twice daily on days 0-14.
COHORT II: Beginning within 6 hours of T cell infusion, patients receive high-dose aldesleukin IV 3 times daily on days 0-5.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and every 3 months thereafter for up to 1 year.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: | Cassian Yee | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Yee, Cassian, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00438984 History of Changes |
| Other Study ID Numbers: | 2140.00, NCI-2010-01280, R21CA128283 |
| Study First Received: | February 20, 2007 |
| Last Updated: | June 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Cyclophosphamide Aldesleukin Interleukin-2 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |